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Dockets Management

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Food and Drug Administration

Circulatory System Devices Panel

November 29th and 30th


November 29 Abbott Xience

2007-4333s1-01- FDA Post Approval Studies Update - Danica Marinac-Dabic, MD, PhD, Chief, Epidemiology Branch, Office of Surveillance and Biometrics (pdf)

2007-4333s1-02- FDA Presentation - (XIENCE™ V Everolimus Eluting Coronary Stent System FDA Review of P070015) - Heather L. Agler, PhD, Division of Cardiovascular Devices, Office of Device Evaluation  (pdf)

2007-4333s1-03- Abbott Vascular (Sponsor) Presentation - (XIENCE™ V Everolimus Eluting Coronary Stent System FDA Review PMA# P070015) – Gary C. Johnson, Vice President, Regulatory Affairs, Clinical Research and Quality Assurance (pdf)

November 30 Heart Mate II

2007-4333s2-04- FDA Presentation FDA Review Summary - Thoratec Corporation HeartMate II Left Ventricular Assist System PMA P060040- Eric Chen M.S. (pdf)


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