BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P970035 · Supplement: S029 · Decision Oct 4, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    S7 WITH DISCRETE TECHNOLOGY (TM) OTW/RAPID EXCHANGE CORONARY STENT SYSTEM
    PMA Number
    P970035
    Supplement Number
    S029
    Device Class
    FDA Class 3
    Product Code
    MAF
    Generic Name
    STENT, CORONARY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 4, 2001
    Date Received
    August 14, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE S7 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE (OTW) AND RAPID EXCHANGE (RX) CORONARY STENT SYSTEMS USING THE AV100 BALLOON MATERIAL. (NOTE THAT ALTHOUGH THIS MATERIAL WAS INCLUDED IN PRODUCT USED IN THE CLINICAL TRIAL REPORTED IN SUPPLEMENT 22, APPROVAL WAS ONLY SOUGHT AND GRANTED FOR THE AV2000 BALLOON MATERIAL.)

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary