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

    Stent, Coronary

    PMA: P970035 · Supplement: S016 · Decision May 14, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    GFX 2 OVER-THE-WIRE CORONARY STSENT SYSTEM
    PMA Number
    P970035
    Supplement Number
    S016
    Device Class
    FDA Class 3
    Product Code
    MAF
    Generic Name
    STENT, CORONARY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 14, 1999
    Date Received
    April 26, 1999
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    The 30-Day Notice requested that GFX(R) ring components annealed at 985 degrees Celsius for 20 minutes be utilized for the manufacturing of the GFX2 stent component. The change is being requested in order to utilize the existing inventory of GFX ring components for the manufacture of GFX2 stent.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary