BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P910077 · Supplement: S025 · Decision Dec 2, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    VENTAK MINI ACID FAMILY SYSTEMS
    PMA Number
    P910077
    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
    December 2, 1998
    Date Received
    September 10, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for VENTAK(R) MINI(TM) IV Models 1790, 1792, 1793, and 1796; VENTAK(R) MINI(TM) III+HE Models 1788 and 1789; VENTAK(R) MINI(TM) Application Software Model 2840 (Version 4.0); and the sensitivity adjustment for VENTAK(R) MINI(TM) and MINI(TM) II ICD 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)