BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aortic Valve, Prosthesis, Percutaneously Delivered

    PMA: P100041 · Supplement: S008 · Decision Aug 20, 2012
    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
    PMA Number
    P100041
    Supplement Number
    S008
    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
    August 20, 2012
    Date Received
    March 8, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO ADD THE EDWARDS TRANSCATHETER BALLOON CATHETERS, MODELS 9350BC20 AND 9350BC23 WITH A WORKING BALLOON LENGTH OF 4 CM, AND TO ADD SOME NEW CONTROL ENVIRONMENTS AT THE DRAPER FACILITY IN DRAPER, UTAH TO ACCOMMODATE THE MANUFACTURE OF THESE CATHETERS AT THAT FACILITY.

    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