BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aortic Valve, Prosthesis, Percutaneously Delivered

    PMA: P110021 · Supplement: S004 · Decision Jul 2, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Aortic Valve, Prosthesis, Percutaneously Delivered
    Trade Name
    EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSAPICAL AND TRANSFEMORAL ACCESSORIES
    PMA Number
    P110021
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    NPT
    Generic Name
    Aortic valve, prosthesis, percutaneously delivered
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 2, 2013
    Date Received
    December 4, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR DESIGN MODIFICATIONS TO THE ASCENDRA BALLOON CATHETER, MODELS 9100BCL23 (23MM) AND 9100BCL26 (26MM), AND THE ASCENDRA INTRODUCER SHEATH SET, MODEL 91001S. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ASCENDRA 3 DELIVERY SYSTEM, MODELS 9120AS23 (23MM) AND 9120AS26 (26MM) AND ASCENDRA 3 INTRODUCER SHEATH SET, MODEL 9120IS (26F) AND IS INDICATEDFOR THE TRANSAPICAL DELIVERY OF THE EDWARDS SAPIEN TRANSCATHETER HEART VALVE (DELIVERY SYSTEM) AND FOR THE INTRODUCTION AND REMOVAL OF DEVICES USED WITH THE EDWARDS SAPIEN TRANSCATHETER HEART VALVE (INTRODUCER SHEATH SET).

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NPT Aortic Valve, Prosthesis, Percutaneously Delivered