BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980050 · Decision Jun 14, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOF
    PMA Number
    P980050
    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
    June 14, 2000
    Date Received
    December 24, 1998
    Expedited Review
    N
    Docket Number
    00M-1389

    Advisory Committee Statement

    APPROVAL FOR THE MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), MODEL 9961 PROGRAMMER APPLICATION SOFTWARE, AND MEDTRONIC(R) SPRINT(TM) MODEL 6943 STEROID ELUTING, SCREW-IN, ATRIAL/VENTRICULAR LEAD. THIS SYSTEM IS INDICATED FOR USE IN ICD PATIENTS EITHER WITH ATRIAL TACHYARRHYTHMIAS OR WHO ARE AT SIGNIFICANT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS. PATIENTS INDICATED FOR AN ICD ARE THOSE PATIENTS WHO ARE AT RISK OF SUDDEN DEATH DUE TO VENTRICULAR...

    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)