BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980050 · Supplement: S001 · Decision Apr 6, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    JEWEL AF SYSTEM
    PMA Number
    P980050
    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
    April 6, 2001
    Date Received
    June 15, 2000
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    01M-0254

    Advisory Committee Statement

    APPROVAL FOR THE MEDTRONIC(R) MODEL 7250 JEWEL(R) AF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM, MEDTRONIC MODEL 9465 INCHECK(TM) PATIENTS ASSISTANT AND THE MEDTRONIC TRANSVENE(R) CS/SVC MODEL 6937A LEAD. THE SYSTEM IS INTENDED TO PROVIDE PACING, CARDIOVERSION AND DEFIBRILLATION FOR TREATMENT OF PATIENTS WITH SYMPTOMATIC DRUG REFRACTORY ATRIAL FIBRILLATION AND/OR LIFE-THREATENING VENTRICULAR TACHYARRHYTHMIAS.

    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)