BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980050 · Supplement: S006 · Decision Aug 29, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    MEDTRONIC MODEL 7250 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (AF ONLY STUDY)
    PMA Number
    P980050
    Supplement Number
    S006
    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
    August 29, 2001
    Date Received
    June 27, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE POST-APPROVAL PROTOCOL FOR CONTINUED FOLLOW-UP OF THE PATIENTS WHO RECEIVED THE MODEL 7250 FOR THE AF ONLY INDICATION.

    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)