BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P940024 · Decision Jul 3, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB.
    PMA Number
    P940024
    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
    July 3, 1997
    Date Received
    July 8, 1994
    Expedited Review
    N
    Docket Number
    97M-0500

    Advisory Committee Statement

    APPROVAL FOR THE GUARDIAN(TM) ATP II MODEL 4211 IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR SYSTEM. THE GUARDIAN(TM) ATP II MODEL 4211 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR HEREAFTER REFERRED TO AS THE 4211 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM CONSISTS OF THE FOLLOWING: THE GUARDIAN(TM) ATP II MODEL 4211 IMPLANTABLE CARDIOVERTER DEFBRILLATOR; IMPLANTABLE DEFIBRILLATOR PATCH LEAD MODEL 040-105, 040-106, 040-107, 040-128, 040-129 AND 040-130; MODEL 4510 IMPLANT SUPPORT DEVICE; GENERIC 4211 PERSONALITY MODEULE; AND SYSTEM ACCESSORIES (ADAPTER MODELS 040-051, 040-052, 040-047, 040-055, 033-330, AND 033-320, MODEL 042-018 PATIENT INTERFACE MODULE, MODEL 040-021, STYLET KIT AND CABLE MODELS 042-010, 042-011, 042-015, 042-238 AND 042-017). THE 4211 SYSTEM IS INDICATED FOR USE IN PATIENTS WHO ARE AT HIGH RISK OF SUDDEN DEATH DUE TO VENTRICULAR FIBRILLATION AND/OR VENTRICULAR TACHYRHYTHMIAS AND WHO HAVE EXPERIENCED ONE OF THE FOLLOWING SITUATION: SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST (MANIFESTED BY A LOSS OF CONSCIOUSNESS) DUE TO VENTRICULAR TACHYRHYTHMIA OR RECURRENT, POORLY TOLERATED SUSTAINED VENTRICULAR TACHYCARDIA (VT). NOTE:THE CLINICAL OUTCOME FOR HEMODYNAMICALLY STABLE, SUSTAINED-VT PATIENTS IS NOT FULLY KNOWN. SAFETY AND EFFECTIVENESS STUDIES HAVE NOT BEEN CONDUCTED.

    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)