BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: P010012 · Supplement: S036 · Decision Mar 23, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Implantable Pulse Generator, Pacemaker (Non-Crt)
    Trade Name
    CONTAK RENEWAL 1/3/3HE CRT-D DEVICES
    PMA Number
    P010012
    Supplement Number
    S036
    Device Class
    FDA Class 3
    Product Code
    LWP
    Generic Name
    Implantable pulse generator, pacemaker (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 23, 2007
    Date Received
    November 2, 2004
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE CONSULT SOFTWARE MODEL 2845 V2.10 TO BE USED TO ENABLE THE ABILITY TO PROGRAM THE V-V TIMING INTERVAL IN THE CONTAK RENEWAL MODEL H135; CONTAK RENEWAL 2 MODELS H170 AND 175; AND CONTAK RENEWAL 3 HE MODELS H177 AND H179 CRT-D DEVICES.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LWP Implantable Pulse Generator, Pacemaker (Non-Crt)