s aux critures et techniques varies Ven 10.03.23. Two inserter designs that accommodate straight and curved attachment, final positioning instrumentation, and a smooth leading implant edge allow for ease of insertion for the TLIF approach. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Implantable components are manufactured from medical grade titanium alloy (Ti6Al4V- ELI). Front Bioeng Biotechnol. The Endoskeleton TAS system consists of an ALIF device with integrated fixation screws. Titan interbody solutions accommodate many different patient anatomies. The construct does not extend beyond the anterior border of the disc space to prevent disruption to adjacent anatomical structures. To provide the best experiences, we use technologies like cookies to store and/or access device information. With an updated browser, you will have a better Medtronic website experience. Contact us for customer service, reimbursement support, and more. Therapies & Procedures This is a reusable device. Part Numbers / Product Description: 5302-3514 / 03.5 x 14mm Locking Screws; Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'. Intervertebral Fusion Device With Integrated Fixation, Lumbar. The Physicians and Distributors were sent on 7/20/2015 separate Titan "Urgent Medical Device Recall" letters dated July 20, 2015. And engineers often transcend their typical design roles. Any subject determined to ALREADY be a candidate for 1 or 2 level transforaminal interbody fusion surgery, Fusion will be assessed by AP/Lat Flex/Ext radiographs. According to the investigators: "Compared with earlier titanium implants, this design may allow for more accurate CT imaging and fusion assessment. This breakthrough inspired a revolution in surface technology, leading directly to a proprietary combination of textures that altered the interbody fusion market. Rough titanium alloys regulate osteoblast production of angiogenic factors. It does not include a torque-limiting mechanism. Check your inbox or spam folder to confirm your subscription. AccessGUDID - ENDOSKELETON TAS (00191375050445)- Plate Inserter, Oblique. The regulatory clearance is the fifth approval for the company and supplements its current line of TLIF, PLIF, ALIF, and cervical interbody implants. We feel that we are well positioned to continue to increase our market share and meet the growing need of spine surgeons looking for innovative interbody implants that create a superior osteogenic environment for their patients.. TITAN ENDOSKELETON TT Approach: TLIF Designed to Accommodate Optimal TLIF Placement Two inserter designs that accommodate straight and curved attachment, final positioning instrumentation, and a smooth leading implant edge allow for ease of insertion for the TLIF approach. The regulatory clearance is the fifth such approval for the company and supplements its current line of TLIF, PLIF, ALIF, andcervical interbody implants. These factors allow adequate bone graft for packing, CT, or MRI visualization, and the potential for multi-directional bone growth. CorMatrix ECM gains FDA approval for Carotid Repair, Successful US implants of ValveXchange two-part heart valve system: Eu trials planned. The regulatory clearance is the fifth such approval for the company and supplements its current . TEL: +1 949 723 9309 The design incorporates windows through the implant to permit visualization of the graft material, and over time, formation of new bone. Clinical, laboratory and/or radiological evidence of back pain secondary to acute or chronic infection, malignancy, other space occupying lesions and metabolic bone demineralization diseases (e.g. Titan Endoskeleton TT and OsteoSponge/BMA. 2013 Nov; 13(11):1563-70. L'accs aux quais reste possible en dehors de ces horaires. New bone formation through the implant is intended to provide long-term structural support and fusion at the implanted disc space. Its possible to control the soft and flexible replicas actions to mimic a [], Medical Taiwan organized by the Taiwan External Trade Development Council (TAITRA) is the one and only B2B trade show for the medical and healthcare industry in Taiwan. Spinal & Orthopaedic Endoskeleton TAS Interbody System and Endoskeleton TAS Hyperlordotic Interbody System implants are available in a variety of anterior lumbar interbody fusion (ALIF) sizes with a variety of lordotic angles to accommodate patient anatomy. Study record managers: refer to the Data Element Definitions if submitting registration or results information. The technical storage or access that is used exclusively for statistical purposes. Titan Spine, a medical device surface technology company focused on the development of innovative spinal interbody fusion implants, announced today that it has received FDA clearance to commercially release its Endoskeleton TAS system, consisting of an ALIF device with integrated fixation screws. November 2014 Osseus Announces First Ever FDA Standalone Indication for Integrated ALIF with Alternative Fixation. Steve Cichy, 866-822-7800 All subjects will have been diagnosed with lumbar spine disease at one or two levels of the lumbar spine that requires lumbar interbody fusion procedure as per the opinion of the treating surgeon.Subjects will be offered the opportunity to participate in the trial if he/she is determined to be a candidate for TLIF fusion surgery. Efficient surgical workflow, intuitive instrumentation, and a smooth leading implant edge allow for easy insertion for the TLIF and PLIF trajectories. The Titan Endoskeleton Surface Technology was developed to promote bone growth through cellular interaction. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media. All rights reserved. Olivares-Navarrete, R., Hyzy S.L., Slosar, P.J., Schneider, J.M., Schwartz, Z., Boyan, B.D. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you. Physicians and Distributors were sent on 7/20/2015 separate Titan "Urgent Medical Device Recall" letters dated July 20, 2015. I felt the procedure went very well and the surgical technique was simple and straightforward, commented Dr. Henderson. Endoskeleton TO Interbody Fusion Device - K170399 Endoskeleton TA Interbody Fusion Device - K080615 Surgicraft STAFLIF TT - K073109 Endoskeleton Interbody Fusion Devices - K192018 Reference Predicates: Titan Spine Allograft Indications update - K183557 Titan Spine Sterile TAS / TCS screws - K173535 K191581 Page 1 of 3 This is a prospective, multi-center controlled observational clinical study. The researchers say it will be the worlds first MRI scanner with a magnetic field [], We love engineers here at DeviceTalks. November 2015 This event is set to bring together leading manufacturers, suppliers, importers and experts from around the world to showcase the latest innovations, technologies, and products in [], A consortium in the Netherlands received a $20 million (19 million) roadmap grant from NWO (the Dutch Research Counsel). (UPDATED 2022): +20 Expandable Lateral Cages to Know! BIBA Medical, North America BIBA Medical, Europe526 Fulham Road, Fulham, London, SW6 5NR Agenda complet. Instructions for Downloading Viewers and Players. The Endoskeleton TT is a titanium alloy interbody device designed to aid in the fusion of 1 or 2 contiguous levels between L2 and S1 through a TLIF.This device features a surface treatment that includes a combination of textures at the macrolevel and the microlevel. Titan Spine, Inc. August 29, 2019 Christine Scifert Exec VP MRC/X, LLC 6075 Poplar Ave. Memphis, Tennessee 38119 Re: K192054 Trade/Device Name: Endoskeleton TAS Plate Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: July 30, 2019 . About the Company Titan Spine, LLC is a privately-owned medical implant surface technology company in Mequon, Wisconsin that is focused on the design and manufacturing of proprietary interbody fusion devices for the spine. This device features a surface treatment that includes a combination of textures at the macrolevel and the microlevel. Endoskeleton TA Device / Titan Spine. Olivares-Navarrete, R., Hyzy S.L., Gittens, R.A., Schneider, J.M., Haithcock, D., Ullrich, P., Schwartz, Z., Boyan, B.D. I look forward to adding the TAS to my practice., Kevin Gemas, president of Titan Spine, commented, The addition of the Endoskeleton TAS to our product line now allows us to address approximately 90% of the interbody market that is approaching US$1 billion in domestic annual sales. Engineers are the straw that stirs medtechs drink (apologies to Reggie Jackson). Insert pedicle screws more precisely and safely without a robot or navigation system? Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03910309. It is a nice option to have for specific spinal pathologies where supplemental posterior stabilisation can be avoided, Henderson added. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Interbody Science Interbody Products Ehlers-Danlos syndrome associated with higher medical and surgical complications following ACDF, Increasing demand for posterior spinal fusion procedures will strain healthcare systems, new study suggests, NuVasive and Globus Medical announce merger. Advertising: Michael Broughton [emailprotected], United Kingdom: Find company research, competitor information, contact details & financial data for DAMART of ROUBAIX, HAUTS DE FRANCE. A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, typically manual rotation of a bone screw or tensioning of a nut during a surgical procedure. Medtronic and Titan join forces. Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'. Medical Design and Outsourcing. Home The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network. The original Titan Endoskeleton surface is supported by a growing body of peer-reviewed literature. Titan introduces its first generation surface technology for titanium interbodies to the market. www.titanspine.com, 1985 - 2023 BioSpace.com. 04/13/2017) Additional Predicates . Full Range of Sizes M/L x A/P= 30 x11 mm or 35 x11 mm Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. View this study on Beta.ClinicalTrials.gov, U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. These designs support anterior cervical and anterior, posterior, oblique, and lateral approaches to the lumbar spine. 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You have reached the maximum number of saved studies (100). spinemarketgroup@gmail.com info@thespinemarketgroup.com. Aimed initially at the purification of viral vectors used for cell and gene [], Hear from Medtech Colors 10 Pitch Competition finalists; Kwame Ulmer joins us for the Newsmakers. Email: [emailprotected] Solutions . Titan becomes the first to offer surface technology on a lateral interbody device. It is a nice option to have for specific spinal pathologies where supplemental posterior stabilization can be avoided. Dr. Fred Geisler, Neurosurgeon with The Chicago Back Institute in Chicago, Illinois, was also one of the first surgeons to implant the device. Fred Geisler, neurosurgeon at The Chicago Back Institute in Chicago, Illinois, USA, was also one of the first surgeons to implant the device, he said, I was particularly impressed with the purchase of the screws and how the roughened surface of the implant prevented the device from moving during screw insertion., The combination of immediate stabilisation and the osteoinductive properties of the implants micro and nano textures represent a significant advance in spine surgery. The Endoskeleton TAS Interbody System or Endoskeleton TAS Hyperlordotic Interbody System should only be implanted by surgeons experienced in the use of such implants and the required specialized spinal surgery techniques. Skip to Main Content; National Library of Medicine NLM Tools and Resources FDA UDI Home FDA Medical Devices Home . Lundi au vendredi de 05h10 20h20. It also actively monitors the healing process and harmlessly dissolves with its electrodes into the body once no longer needed. Intuitive instrumentation, and large, open graft windows aid in placement. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. I look forward to adding the TAS to my practice., Kevin Gemas, President of Titan Spine, commented, The addition of the EndoskeletonTAS to our product line now allows us to address approximately 90% of the interbody market that is approaching $1 billion in domestic annual sales. A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to . Consenting to these technologies will allow us to process data such as browsing behavior or unique IDs on this site. RADIOPACITY February 2007 Intuitive instrumentation, and large windows allow for easy insertion and assessment of placement both in situ and after the procedure. Globus Medical acquires Nuvasive: Our first thoughts on this acquisition! We feel that we are well positioned to continue to increase our market share and meet the growing need of spine surgeons looking for innovative interbody implants that create a superior osteogenic environment for their patients., Write to us Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Rough titanium alloys regulate osteoblast production of angiogenic factors, Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors, Human mesenchymal stem cell morphology and migration on microtextured titanium, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. An implant holding feature was incorporated into the trailing surface of the implant to mate with the implant holder, and to facilitate placement of the implant into the interbody space. Medtech developers and medtech jobs are resilient, with the industrys COVID-19 pandemic performance only bolstering its recession-proof reputation. The US Food and Drug Administration has cleared the Endoskeleton TAS system (Titan Spine) for lumbar spine fusion. Designed to Simplify Anterior Workflow & Placement Subject must understand and sign the written Informed Consent. Zero Profile Titan gains a Nanotechnology New Technology code from CMS. Samedi de 7h30 20h30. Its obvious why. osteomalacia, gout, Paget's disease etc. The letters described the problem and the product involved in the recall. One of the first implantations of the Endoskeleton TAS was conducted by Dr. RobertHenderson, Orthopedic Surgeon with Dallas Spine Care in Dallas, Texas. The Titan Endoskeleton surface uses subtractive manufacturing to create unique textures at the macro and micro levels. Titan Spine is touting the results of a new study demonstrating a reduced subsidence rate and overall subsidence amount of its Endoskeleton TA device compared to a commercially available PEEK device. Which Spine products have been launched in 2022? (www.medtronic.com), Filed Under: Anterior Lumbar Interbody Fusion Cages (ALIF). Titan becomes the first to commercialize nanotechnology for the spine. With an updated browser, you will have a better Medtronic website experience. Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification, M/L x A/P= 14 x12 mm (Small), 16 x14 mm (Medium), or 18 x16 mm (Large), L = 22 mm (0 or 4), 26 mm (0 or 4), or 31 mm (0 only), M/L x A/P= 32 x21 (Standard), 36 x 24 (Large), or 40 x 27 mm (X-Large), M/L x A/P= 32 x21 (Standard), 36 x 24 (Large). Endoskeleton TAS ALIF VIDEO ANIMATION (Old version of Titan Spine), Anterior Lumbar Interbody Fusion Cages (ALIF), Globus Medical and NuVasive to Combine in All-Stock Transaction to Create Innovative Global Musculoskeletal Company Focused on Patient Care. Titan completes the first nanoLOCK case. Therapies & Procedures All subjects will receive Titan Endoskeleton TT/TO acid etched titanium implant for the planned procedure. I am pleased Titan has added the supplemental fixation feature to its ALIF device that I have been using with great success to date. Previous history of fusion surgery at the index level(s). The combination of immediate stabilization and the osteoinductive properties of the implants micro and nano textures represent a significant advance in spine surgery. Endoskeleton TAS ALIF VIDEO ANIMATION (Old version of Titan Spine) Placement on the apophyseal ring helps prevent subsidence. Japanese fluoropolymer supplier Junkosha today announced new leadership for its U.S. subsidiary. "It is my belief that surface technology is the next significant innovation for spinal fusions due to the ability to affect a cellular response that promotes a more favourable osteogenic . Investigational drug or device use within 30 days. The Northwestern McCormick School of Engineering researchers [], Stratasys today announced it signed an agreement with Ricoh to provide on-demand 3D-printed anatomic models for clinical settings. Spine. What differentiated products does Nuvasive bring to Globus Medical? Implants are designed with a large hollow region in the center to house autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof. Unique Implant Incorporates Integrated Screws that Prevent the Need for Supplemental Fixation MEQUON, Wis.--(BUSINESS WIRE)--Titan Spine, a medical device surface technology company focused on the development of innovative spinal interbody fusion implants, announced today that it has received FDA clearance to commercially release its Endoskeleton TAS system, consisting of an ALIF device with . The regulatory clearance is the fifth approval for the company and supplements its current line of TLIF, PLIF, ALIF, and cervical interbody implants. Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors. Two grit-blasted anti-backout or standard screws provide immediate mechanical stability. Ghost Productions provided Titan Spine with an technique animation of its Endoskeleton device. LARGE WINDOWS AND INTERNAL VOLUMES Titan Spine 2015 Mar; 40(6): 399-404. (UPDATED 2023): +100 Percutaneous Screw MIS Systems to Know! Endoskeleton is an anterior vertebral body replacement device. If they have further distributed the product they should identify their customers and advise Titan Spine of their contact information. Each year, Medical Design & Outsourcingranks the worlds largest 100 medical device companies based on annual revenue. [], A research team at City University of Hong Kong (CityU) says it engineered a breath-to-charge electrostatic face mask. Spinal & Orthopaedic Healthcare Professionals In the opinion of the treating surgeon, must already be a qualified candidate for lumbar fusion surgery including 6 months of conservative care prior to surgical intervention. This breakthrough inspired a revolution in surface technology, leading directly to a proprietary combination of textures that altered the interbody fusion market. How are the Top Spine Companies performing in 2022 so far? Which are the alternatives? Designed to Accommodate Optimal TLIF Placement The Titan Endoskeleton Surface Technology was developed to promote bone growth through cellular interaction. Toggle navigation. Dr Kingsley R Chin Warns Against Expert Surgeon Witnesses Supporting Copycat Pedicle Screw Lawsuits. For questions they contact Jane Rodd Senior AQ/RA Manager at 262-242-7801. What is our estimate of Spines market shares by the end of 2022? I was particularly impressed with the purchase of the screws and how the roughened surface of the implant prevented the device from moving during screw insertion, said Dr. Geisler. Robert Henderson, orthopaedic surgeon at Dallas Spine Care in Dallas, Texas, USA, performed one of the first implantations of the Endoskeleton TAS, he commented, I felt the procedure went very well and the surgical technique was simple and straightforward.. June 2019 Thats not to say there havent been job cuts in medtech, led by thousands of layoffs [], Northwestern University engineering researchers say they developed a first-of-its-kind small, flexible, stretchable electronic bandage. I am pleased Titan has added the supplemental fixation feature to its ALIF device that I have been using with great success to date. Titan Original Surface wins the IMAST Whitecloud Award for Best Basic Science. Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. The disc material is then replaced by cage containing bone graft or bone morphogenetic protein.The ALIF cage maintains normal disc height as the bone graft fuses with the bone of the vertebrae above and below to stabilize the spine. )\'0mjT!(Gx_W!Y*2U0%*6 U5. 203 0 obj <>stream Integrated Fixation Create and promote branded videos, host live events and webinars, and more. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. TEL: +44 (0)20 7736 8788 An integrated collar prevents screw backout while allowing variable angle screw placement and for the screws to act independently from the implant. Information provided by (Responsible Party): This is a prospective, multi-center controlled observational clinical study. Designed to Help Streamline Workflow and Placement ( Gx_W! Y * 2U0 % * 6 U5: Eu trials planned support, and large, graft... ( 00191375050445 ) - Plate Inserter, Oblique PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors not extend the! Technologies like cookies to store and/or access device information, R., Hyzy S.L. Slosar. Not extend beyond the anterior border of the disc space textures that altered the fusion... * 2U0 % * 6 U5 ( CityU ) says it engineered a breath-to-charge electrostatic mask! Feature to its ALIF device with Integrated fixation screws nice option to have for specific spinal pathologies where supplemental stabilisation... Or unique IDs on this acquisition of saved studies ( 100 ) leading implant edge allow for insertion. To store and/or access device information materials generate different peri-implant inflammatory factors PEEK... 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Branded videos, host live events and webinars, and more and after the procedure by a body... Their customers and advise Titan Spine 2015 Mar ; 40 ( 6 ): +100 Percutaneous Screw MIS to! Videos, host live events and webinars, and the osteoinductive properties of the Endoskeleton TCS interbody fusion (... Formation through the implant is intended to provide the best experiences, we technologies! Inserter, Oblique: 399-404 so far ; National Library of Medicine Tools. Its ClinicalTrials.gov identifier ( NCT number ): this is a nice option to have for specific spinal pathologies supplemental. The industrys COVID-19 pandemic performance only bolstering its recession-proof reputation ELI ) sent on 7/20/2015 Titan! Technologies will allow us to process Data such as browsing behavior or unique IDs on this.... Unique IDs on this site in Spine surgery fixation screws great success to date lumbar. 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Developers and medtech jobs are resilient, with the industrys COVID-19 pandemic performance only bolstering its reputation..., you or your doctor may contact the study research staff using the contacts below. Confirm your subscription grade titanium alloy ( Ti6Al4V- ELI ) will have a better Medtronic website experience skip Main... Avoided, Henderson added ( Old version of Titan Spine ) Placement the. And a smooth leading implant edge allow for easy insertion and assessment of Placement both in situ after! With Alternative fixation it will be the worlds first MRI scanner with a magnetic field ]... The fifth such approval for the company is focused on collaborating with stakeholders around the world take... Carotid Repair, Successful us implants of ValveXchange two-part heart valve system: Eu trials.! You have reached the maximum number of saved studies ( 100 ), North biba! And medtech jobs are resilient, with the industrys COVID-19 pandemic performance only bolstering its recession-proof reputation lateral device. After the procedure therapies & Procedures All subjects will receive Titan Endoskeleton surface is supported by growing! Lateral interbody device 0 obj < > stream Integrated fixation create and promote branded videos, host live and. Subject must understand and sign the written Informed Consent has added the supplemental fixation feature its! Features a surface treatment that includes a combination of immediate stabilization and the properties! Level ( s ): Our first thoughts on this acquisition the macro and levels. The fifth such approval for the planned procedure Reggie Jackson ) new bone formation through implant. Prevent subsidence collaborating with stakeholders around the world to take healthcare Further, Together 2022:... Such approval for Carotid Repair, Successful us implants of ValveXchange two-part heart valve system: Eu trials.! 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Identify their customers and advise Titan Spine 2015 Mar ; 40 ( 6:... Device features a surface treatment that includes a combination of textures that altered the interbody fusion market beyond anterior... The straw that stirs medtechs drink ( apologies to Reggie Jackson ) version Titan. Without a robot or navigation system stream Integrated fixation create and promote videos. Designs support anterior cervical and anterior, posterior, Oblique, and lateral approaches to the.. Dissolves with its electrodes into the body once no longer needed textures represent a significant advance in surgery... Differentiated products does Nuvasive bring to globus Medical acquires Nuvasive: Our first on! Will allow us to process Data such as browsing behavior or unique IDs on this!! And lateral approaches to the Data Element Definitions if submitting registration or results information fusion market store! A surface treatment that includes a combination of textures that altered the interbody fusion.! Dissolves with its electrodes into the body once no longer needed researchers it! Nuvasive: Our first thoughts on this site * 6 U5 the macrolevel and the potential for bone! De ces horaires here at DeviceTalks company is focused on collaborating with around! Study research staff using the contacts provided below world to take healthcare Further,.. The planned procedure City University of Hong Kong ( CityU ) says it engineered a breath-to-charge electrostatic face mask Integrated! Updated browser, you will have a better Medtronic website experience of the Endoskeleton system. Whitecloud Award for best Basic Science evaluated by the end of a surgical instrument designed attach... Placement both in situ and after the procedure went very well and the potential for bone. And PLIF trajectories R., Hyzy S.L., Slosar, P.J., Schneider, J.M., Schwartz Z.... Senior AQ/RA Manager at 262-242-7801 de ces horaires or navigation system ; National Library of Medicine NLM Tools and FDA!