BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: P010012 · Supplement: S183 · Decision Jul 30, 2009
    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 FAMILY OF CRT-D
    PMA Number
    P010012
    Supplement Number
    S183
    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
    July 30, 2009
    Date Received
    June 19, 2008
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE PROGRAMMER SOFTWARE APPLICATION MODEL 2845 VERSION 4.34 FOR THE CONTAK RENEWAL (MODEL H135), CONTAK RENEWAL 3 (MODELS H170, H175), CONTAK RENEWAL 3 HE (MODELS H177, H179), CONTAK RENEWAL 3 RF (MODELS H210, H215, H250, H255), AND CONTAK RENEWAL 3 RF HE (MODELS H217, H219, H257, H259).

    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)