BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P910073 · Supplement: S020 · Decision May 15, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD
    PMA Number
    P910073
    Supplement Number
    S020
    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
    May 15, 1996
    Date Received
    May 10, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ENDOTAK C LEAD (MODELS 0060, 0062, 0064, 0065, 0066, 0067, AND 0068), ENDOTAK SQ PATCH LEAD (MODEL 0047 AND 0063), ENDOTAK C LEAD (MODELS 0070, 0072, 0073, 0074, 0075, 0113, AND 0115), ENDOTAK SQ LEAD ARRAY (MODELS 0048 AND 0049), AND ENDOTAK DSP LEAD (MODELS 0092, 0093, 0094, 0095, 0096, 0097, 0123, AND 0125), WHICH REQUESTED APPROVAL TO ADD A PATIENT GROUP TO THE INDICATIONS FOR USE

    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)