BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P890003 · Supplement: S124 · Decision Sep 18, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    THERA/PRODIGY
    PMA Number
    P890003
    Supplement Number
    S124
    Device Class
    FDA Class 3
    Product Code
    NVZ
    Generic Name
    Pulse generator, permanent, implantable
    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
    NVZ Pulse Generator, Permanent, Implantable