BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P910073 · Supplement: S043 · Decision Mar 2, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    ENDOTAK RELIANCE G/SG LEAD MODELS 0180-0187
    PMA Number
    P910073
    Supplement Number
    S043
    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
    March 2, 2004
    Date Received
    December 4, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ADDITION OF AN EPTFE COATING TO THE SHOCK COILS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ENDOTAK RELIANCE G/SG LEAD MODELS AND IS INDICATED FOR PROVIDING PACING AND RATE-SENSING AND TO DELIVER CARDIOVERSION AND DEFIBRILLATION SHOCKS FOR ICD AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS.

    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)