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

    Stent, Coronary

    PMA: P030009 · Supplement: S068 · Decision Oct 24, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    INTEGRITY RX CORONARY STENT SYSTEM,INTEGRITY OTW CORONARY STENT SYSTEM
    PMA Number
    P030009
    Supplement Number
    S068
    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
    October 24, 2013
    Date Received
    September 26, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGES TO THE VISION ASSIST PRECISION WELDER INCLUDING THE ADDITION OF A NEW MOTOR, REPLACEMENT OF THE CHUCK/COLLET FIXTURE, REMOVAL OF THE SCAN BY THE OVERHEAD CAMERA, AND UPDATED SOFTWARE TO ENSURE APPROPRIATE SET-UP IS COMPLETED.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary