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

    Stent, Coronary

    PMA: P970035 · Supplement: S012 · Decision Dec 29, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM;GFX OVER-THE-WIRE CORONARY STENT SYSTEM
    PMA Number
    P970035
    Supplement Number
    S012
    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
    December 29, 1998
    Date Received
    December 11, 1998
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    The 30-Day Notice requested to add an additional step in the manufacturing of multilumen tubing. The additional step would consist of compounding the virgin resin HDPE/Black-Colorant blend prior to the extrusion of multilumen tubing by AVE. The compounding will be done by a vendor via machine mixing, extruded and then re-pelletized to provide compounded resin pellets of the blend required for extrusion of AVE's multilumen tubing.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary