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

    Pulse Generator, Permanent, Implantable

    PMA: P880086 · Supplement: S218 · Decision May 3, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    PACEMAKER FAMILY OF DEVICES (INTEGRITY, IDENTITY, VERITY, SUSTAIN, VICTORY, ZEPHYR, ACCENT FAMILY OF DEVICES)
    PMA Number
    P880086
    Supplement Number
    S218
    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
    May 3, 2012
    Date Received
    April 3, 2012
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    IMPLEMENT ST. JUDE MEDICAL DISTRIBUTION AND LABELING SYSTEM (SDLS) FOR ALL SJM CRMD PRODUCTS.

    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