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

    Pulse Generator, Permanent, Implantable

    PMA: P890003 · Supplement: S397 · Decision Oct 18, 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, Package Adaptor Cable and Vitatron Brilliant S+ VDD Lead
    PMA Number
    P890003
    Supplement Number
    S397
    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
    October 18, 2018
    Date Received
    September 26, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Transfer receiving and incoming inspection activities for device components from Medtronic Rice Creek to Medtronic Puerto Rico Operations Company (MPROC) Villalba/Juncos sites and the FedEx/3PL (Third Party Logistics) facility in Guaynabo, Puerto Rico.

    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