BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Absorbable Coronary Drug-Eluting Stent

    PMA: P150023 · Supplement: S010 · Decision May 30, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Absorbable Coronary Drug-Eluting Stent
    Trade Name
    Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System
    PMA Number
    P150023
    Supplement Number
    S010
    Device Class
    FDA Class 3
    Product Code
    PNY
    Generic Name
    Absorbable coronary drug-eluting stent
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 30, 2018
    Date Received
    March 1, 2018
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for implementation of everolimus BHT manufactured at a new manufacturing site.

    Classifications

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

    Product Code Device Name
    PNY Absorbable Coronary Drug-Eluting Stent