BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P940008 · Supplement: S002 · Decision Aug 20, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS
    PMA Number
    P940008
    Supplement Number
    S002
    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 20, 1996
    Date Received
    February 5, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Other
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A SUPPLEMENT WHICH SATISFIES THE REQUIREMENT TO SUBMIT A POST-APPROVAL STUDY PROTOCOL FOR THE INTERMEDICS EPICARDIAL PATCH DEFIBRILLATION LEADS. THE POST APPROVAL STUDY WAS REQUIRED AS A CONIDTIN OF APPROVAL IN OUR LETTER DATED NOVEMBER 7, 1995

    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)