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

    Stent, Coronary

    PMA: P970035 · Supplement: S027 · Decision May 29, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    S7 WITH DIS OVER-THE WIRE CORONARY STENT SYSTEM AND S7 WITH DISCRETE TECHN RAPID EXCHANGE CORONARY STENT SYSTEM
    PMA Number
    P970035
    Supplement Number
    S027
    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 29, 2001
    Date Received
    May 11, 2001
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE TO THE MANUFACTURING PROCESS TO INCREASE THE LENGTH AND INNER DIAMETER OF THE THIRD AND FOURTH TFE BAKING SHEATHS IN SIZE TO FACILITATE THEIR APPLICATION DURING THE STENT/BALLOON BAKING PROCESS.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary