BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator

    PMA: P180036 · Supplement: S038 · Decision Jul 15, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Implantable Pulse Generator
    Trade Name
    OPTIMIZER Smart System
    PMA Number
    P180036
    Supplement Number
    S038
    Device Class
    FDA Class 3
    Product Code
    QFV
    Generic Name
    Implantable pulse generator
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 15, 2025
    Date Received
    February 19, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for a manufacturing site located at Integer TJS, S. de R.L. de C.V., Calle 5 Norte No. 511 Ciudad Industrial, Tijuana, Baja California, MX 22444 for the manufacture of GUARDIO/VESTA charger devices

    Classifications

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

    Product Code Device Name
    QFV Implantable Pulse Generator