BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Pacemaker Electrode

    PMA: P850089 · Supplement: S036 · Decision Feb 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Permanent Pacemaker Electrode
    Trade Name
    CAPSURE(R) AND CAPSURE(R) SP SILICONE PACING LEADS
    PMA Number
    P850089
    Supplement Number
    S036
    Device Class
    FDA Class 3
    Product Code
    DTB
    Generic Name
    permanent pacemaker Electrode
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 4, 1997
    Date Received
    November 20, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR DISTRIBUTION BY VIATRON, INC. OF THE MODELS CAPSURE(R) Z, 5033, 5934, 5534 AND CAPSUREFIX(R) 4068 UNDER A NEW TRADE NAME. THE DEVICES WILL BE MARKETED UNDER THE TRADE NAMES VITATRON(R) IMPULSE(TM) IMG 49, IMPULSE(TM) IMG 49B, IMPULSE(TM) IMG 49JB, AND PIROUET(TM)+IMU 49B. AND ARE INDICATED FOR CHRONIC PACING AND SENSING OF THE ATRIUM AND/OR VENTRICLE.

    Classifications

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

    Product Code Device Name
    DTB Permanent Pacemaker Electrode