BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P910077 · Supplement: S011 · Decision Feb 5, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    VENTAK(R) PRX (TM) II AICD SYSTEM
    PMA Number
    P910077
    Supplement Number
    S011
    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
    February 5, 1996
    Date Received
    August 25, 1995
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE USE OF MODEL 2872 SOFTWARE APPLICATION, REV. 4.1 AND MODEL 2909 MULTIPLE APPLICATION UTILITY (MAU) WITH THE VENTAK PRX II/III PULSE GENERATOR AND MODEL 2950 PRM

    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)