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Summary Information for: Protégé GPS Self-Expanding Peripheral Stent System
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Consumer Information on: Protégé GPS Self-Expanding Peripheral Stent System
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Added transcripts for Public Workshop – Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs), January 8
The purpose of this workshop was to discuss FDA’s proposal for a risk-based framework for addressing the regulatory oversight of a subset of in vitro diagnostic devices (IVDs) referred to as laboratory developed tests (LDTs), which are intended for clinical use and designed, manufactured and used within a single laboratory, and provide an additional opportunity…
PMA Final Decisions for October 2014
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Presentations and Transcripts added to the UDI 101 and Getting Ready for GUDID webinars
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FDA Voice Blog: A CDRH Priority: Clinical Trials in the U.S.
By: Owen Faris, Ph.D., and Jeffrey Shuren, M.D., J.D. At the Center for Devices and Radiological Health (CDRH), clinical trials are the foundation for our decisions to approve the most important medical devices—products that have the potential to save or sustain life, but that also present the greatest risk to patients. Owen Faris, Ph.D., Clinical…
Use of Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients under Age 18 ? FDA Safety Communication
Date Issued: January 21, 2015 Audiences: Healthcare providers Patients under age 18 with bone grown defects Parents/Guardians of patients under age 18 with bone growth defects Specialties: Pediatrics, Plastic Surgery, Dentistry, Orthopedic Surgery, Neurosurgery Product: Certain recombinant proteins and synthetic peptides mimic bone growth substances normally found in the body and may be added to…
CDRH 2014 Strategic Priorities Update
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Consumer Information on: Medtronic IN.PACT Admiral Paclitaxel-coated PTA Balloon Catheter
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