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PMA Final Decisions for April 2015
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HeartWare Ventricular Assist System ? Updated with Multiple Reasons for Recall
This is one of a series of recalls related to HeartWare® Ventricular Assist Device (HVAD) Recall Class: Class I Dates Recall Initiated: April 29, 2015 Device: HeartWare Ventricular Assist Device (HVAD) Product Codes: 1101, 1103 Serial Numbers: All Heartware systems currently in use Manufacturing and Distribution Dates: January 2008 to March 2015 Devices recalled in…
Class I Medical Device Recall: Zimmer M/L Taper with Kinectiv Technology Prosthesis Femoral Stems and Necks Higher than Expected Levels of Manufacturing Residues
Recall Class: Class I Date Recall Initiated: June 8, 2015 Device: Affected lot numbers and item descriptions are listed below. Manufacturing and distribution dates: March 31, 2015 through April 20, 2015 Use: The Zimmer M/L Taper with Kinectiv Technology Femoral Stems and Necks are Tivanium® alloy implants used for hip replacements that allow the surgeon…
Consumer Information on: Superion InterSpinous Spacer
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Consumer Information on: Radiesse Injectable Implant
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Summary Information for: Superion InterSpinous Spacer
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Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions – Draft Guidance for Investigational Device Exemption Sponsors, Sponsor
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Consumer Information on: Misago Peripheral Stent System
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Public Workshop – Non
The Food and Drug Administration (FDA) is announcing a Public Workshop entitled “Non-Microbial Biomarkers of Infection for In Vitro Diagnostic Device Use.” The purpose of this workshop is to receive input from stakeholders and discuss approaches to establish the performance of non-microbial biomarker assays for differentiating viral from bacterial infections and for diagnosis and assessment…