BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P910073 · Supplement: S016 · Decision Apr 4, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    ENDOTAK SQ LEAD ARRAY MODEL 0048 AND ENDOTAK SQ LEAD PATCH MODEL 0063
    PMA Number
    P910073
    Supplement Number
    S016
    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
    April 4, 1996
    Date Received
    May 12, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ALTERNATIVE MANUFACTURING SITE: CARDIAC PACEMAKERS, INC., DEL CARIBE, ROAD 698 LOT NO. 12, DORADO, PUERTO RICO 00646

    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)