BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: P010015 · Supplement: S031 · Decision Sep 18, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Implantable Pulse Generator, Pacemaker (Non-Crt)
    Trade Name
    INSYNC III
    PMA Number
    P010015
    Supplement Number
    S031
    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
    September 18, 2007
    Date Received
    July 26, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO THE XM485 AND XM486 WIRE BOND TERMINAL BLOCKS FOUND IN MEDTRONIC KAPPA 700, KAPPA 900, ENPULSE, ADAPTA/VERSA/ SENSIA, SIGMA, 350 SERIES, THERA/PRODIGY, KAPPA 400, AND INSYNC-II IMPLANTABLE PULSE GENERATOR AND CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) FAMILIES.

    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)