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

    Absorbable Coronary Drug-Eluting Stent

    PMA: P150023 · Supplement: S009 · Decision Jun 23, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Absorbable Coronary Drug-Eluting Stent
    Trade Name
    Absorb GTi Bioresorbable Vascular Scaffold (BVS) System
    PMA Number
    P150023
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    PNY
    Generic Name
    Absorbable coronary drug-eluting stent
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 23, 2017
    Date Received
    May 17, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Extend the retest period from 60 months to 96 months for everolimus repackaged in Configuration I.

    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