BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P910073 · Supplement: S025 · Decision Jan 27, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    ENDOTAK ENDURANCE RX ENDOCARDIAL DEFIBRILLATION LEADS
    PMA Number
    P910073
    Supplement Number
    S025
    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
    January 27, 1999
    Date Received
    July 30, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Models 0144, 0145 and 0146 endocardial defibrillation leads. The device, as modified, will be marketed under the trade name ENDOTAK(R) ENDURANCE (Rx(TM)) Endocardial Defibrillation Lead and is indicated for use to provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for VENTAK AICD 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)