BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P940008 · Decision Nov 28, 1995
    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 EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMS
    PMA Number
    P940008
    Device Class
    FDA Class 3
    Product Code
    LWS
    Generic Name
    Implantable cardioverter defibrillator (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    November 28, 1995
    Date Received
    March 17, 1994
    Expedited Review
    N
    Docket Number
    96M-0202

    Advisory Committee Statement

    APPROVAL APPLICATION (PMA) FOR THE RES-Q ACD (ARRYTHMIA CONTROL DEVICE) EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMS WHICH CONSIST OF THE FOLLOWING: MODEL 101-01 & 101-01R RES-Q IMPLANTABLE ARRHYTHMIA CONTROL DEVICE; MODEL 531-30 RX2000 GRAPHICS PROGRAM MODULE TO BE USED WITH INTERMEDICS COMMERCIALLY AVAILABLE MODEL 522-06 RX2000 GRAPHICS PROGRAMMER; MODELS 497-05, 497-06, AND 497-09 RIGHT VENTRICULAR (RV) DEFIBRILLATION/PACING LEADS; MODEL 497-15 SUBCUTANEOUS PATCH LEAD; MODEL 497-16 SUPERIOR VENA CAVA (SVC) LEADS; MODELS 497-01, 497-02, 497-11, AND 497-12 EPICARDIAL PATCH LEADS; MODELS A67 AND L67 COMMERCIALLY AVAILABLE CPI EPICARDIAL PATCH LEADS; MODEL 370-01 ADAPTER; MODEL 370-21 Y-ADAPTER; MODEL 370-04 TEST BOX; MODELS 370-03 AND 370-23 PATIENT CABLES; MODEL 370-05 TEST LOAD; MODEL 370-02 ACCESSORY KIT; MODEL 370-10 LEAD CAPS; AND MODELS 370-11, 370-12, 370-13, 370-14, 370-15,370-16, 370-48, AND 370-49 STYLETS. THIS DEVICE IS INDICATED FOR USE IN PATIENTS WHO ARE AT HIGH RISK OF SUDDEN DEATH DUE TO VENTRICULAR ARRHYTHMIAS AND HAVE EXPERIENCED ONE OF THE FOLLOWING SITUATIONS: (1) SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST (MANIFESTED BY A LOSS OF CONSCIOUSNESS) DUE TO A VENTRICULAR TACHYARRHYTHMIA, OR (2) RECURRENT, POORLY TOLERATED SUSTAINED VENTRICULAR TACHYCARDIA (VT).

    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)