BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P830060 · Supplement: S052 · Decision Nov 21, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    BI-DIRECTIONAL TORQUE WRENCH(MODEL 6942)
    PMA Number
    P830060
    Supplement Number
    S052
    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
    November 21, 2003
    Date Received
    October 30, 2003
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A LABELING CHANGE TO INCLUDE TEXT VERSIONS AND MORE DESCRIPTIVE APPLICATION DIAGRAMS FOR USING THE BI-DIRECTIONAL TORQUE WRENCH (MODEL 6942) AND HEX WRENCH (MODEL 6501). THE NEW LABELING ALSO SPECIFIED THAT THE DEVICE IS STERILIZED, NON-PYROGENIC AND SINGLE USE ONLY.

    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)