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

    Stent, Carotid

    PMA: P030047 · Supplement: S053 · Decision Jan 8, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Stent, Carotid
    Trade Name
    PRECISE® PRO RX Nitinol Stent System; PRECISE® PRO Transcarotid Stent System
    PMA Number
    P030047
    Supplement Number
    S053
    Device Class
    FDA Class 3
    Product Code
    NIM
    Generic Name
    Stent, carotid
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 8, 2026
    Date Received
    December 10, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval to change the receiving inspection level for 15 part numbers

    Classifications

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

    Product Code Device Name
    NIM Stent, Carotid