BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P890003 · Supplement: S387 · Decision Mar 16, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    CapSure VDD 2 Lead, Servuce Kit-Pacemaker Repair Kit, and Vitatron Brilliant S+ VDD Lead
    PMA Number
    P890003
    Supplement Number
    S387
    Device Class
    FDA Class 3
    Product Code
    NVZ
    Generic Name
    Pulse generator, permanent, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 16, 2018
    Date Received
    February 22, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    a manufacture process change, to incorporate the Device History Record (DHR) review optimization as part of the manufacture process for the devices and site listed in the file.

    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