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

    Stent, Coronary

    PMA: P970035 · Supplement: S005 · Decision Sep 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    MICRO STENT II & GFX OVER-THE-WIRE CORONARY STENT SYSTEMS
    PMA Number
    P970035
    Supplement Number
    S005
    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
    September 30, 1998
    Date Received
    September 18, 1998
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Requested a change to utilize a circular "ring" light source to apply the UV light during the UV adhesive curing process. The requested change will provide constant 360 degree application of UV light to the UV adhesive and will no longer require rotation of the catheter assembly. This process change will eliminate the need for nitrogen cooling gas and will reduce the process time for the distal luer bond from 60 seconds to 38 seconds.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary