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

    Stent, Renal

    PMA: P110001 · Supplement: S021 · Decision Jul 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Stent, Renal
    Trade Name
    RX HERCULINK ELITE RENAL STENT SYSTEM
    PMA Number
    P110001
    Supplement Number
    S021
    Device Class
    FDA Class 3
    Product Code
    NIN
    Generic Name
    STENT, RENAL
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 2, 2025
    Date Received
    June 2, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    reduced incoming inspection plan for the cobalt chromium tubing

    Classifications

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

    Product Code Device Name
    NIN Stent, Renal