BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P930035 · Supplement: S001 · Decision Sep 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    VENTAK(R) P3 AICD(TM) SYSTEM
    PMA Number
    P930035
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    LWS
    Generic Name
    Implantable cardioverter defibrillator (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 8, 1995
    Date Received
    November 10, 1994
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR VENTAK P3 W/VENTAK SOFTWARE MODULE, ENDOTAK C LEAD, ENDOTAK SQ PATCH LEAD, ENDOTAK SQ LEAD ARRAY, AICD Y CONNECTOR, EPICARDIAL PATCH LEAD; SOFTWARE MODULE MODEL 2836 REVISION 2.1 SOFTWARE; AND ALTERNATE STERILIZATION PROCESS

    Classifications

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

    Product Code Device Name
    LWS Implantable Cardioverter Defibrillator (Non-Crt)