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

    Pulse Generator, Permanent, Implantable

    PMA: P890003 · Supplement: S300 · Decision Jan 16, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    MYCARELINK PATIENT MONITOR, MYCARELINK READER FRU
    PMA Number
    P890003
    Supplement Number
    S300
    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
    January 16, 2014
    Date Received
    December 23, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN THE TEST EQUIPMENT/TEST METHOD USED IN THE QUALITY CONTROL INSPECTION PROCESS OF THE PRINTED CIRCUIT BOARD ASSEMBLIES USED IN THE MYCARELINK PATIENTMONITOR.

    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