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

    Stent, Coronary

    PMA: P970035 · Supplement: S024 · Decision Mar 19, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    DISCRETE TECHNOLOGY(TM)OVER-THE-WIRE/RAPID EXCHANGE CORONARY STENT SYSTEM
    PMA Number
    P970035
    Supplement Number
    S024
    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
    March 19, 2001
    Date Received
    February 20, 2001
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE FROM AN OIL-BASE COOLANT USED DURING RING MACHING PROCESS TO A WATER-BASE COOLANT, AND PROPOSES TO CHANGE THE ALCOHOL AND HFE SOLVENT CLEANER USED DURING RING MACHINING TO A WATER-BASE CLEANING SOLUTION FOR BOTH THE S670 AND S660 PRODUCTS.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary