BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P890003 · Supplement: S265 · Decision May 30, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    SYNERGYST II PACING SYSTEM
    PMA Number
    P890003
    Supplement Number
    S265
    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
    May 30, 2013
    Date Received
    November 29, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE IMPLEMENTATION OF A DF-4 LEAD COMPATIBLE, CRIMPABLE ALLIGATOR CLIP ONTO THE SURGICAL CABLES, PROCESS IMPROVEMENTS FOR THE SPLICE YOKE OF THE CABLES AND A CHANGE TO THE WIRE GAUGES USED IN THE 2292 CABLE ASSEMBLY.

    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