BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Superficial Femoral Artery

    PMA: P180003 · Supplement: S005 · Decision Mar 1, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37

    Basic Information

    Device Name
    Stent, Superficial Femoral Artery
    Trade Name
    BioMimics 3D Vascular Stent System
    PMA Number
    P180003
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    NIP
    Generic Name
    STENT, SUPERFICIAL FEMORAL ARTERY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 1, 2022
    Date Received
    October 14, 2021
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of an alternative sterilization site located at Synergy Health Sterilization UK Ltd, STERIS AST Unit 1, Alpha Court, Capitol Park, Thorne, DN8 5TZ, United Kingdom, addition of a new sterilization cycle, an alternative load configuration and ability to perform endotoxin testing on non-sterile samples in the current laboratory.

    Classifications

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

    Product Code Device Name
    NIP Stent, Superficial Femoral Artery