BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P000022 · Supplement: S001 · Decision Dec 14, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM
    PMA Number
    P000022
    Supplement Number
    S001
    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
    December 14, 2000
    Date Received
    November 6, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN THE LABELING TO THE BESTENT(TM) 2 WITH DISCRETE TECHNOLOGY(TM) RAPID EXCHANGE (RX) CORONARY STENT DELIVERY SYSTEM. THE DEVICE IS NOW INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYNPTOMATIC ISCHENIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS (LENGTH <= 30 MM) IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM. LONG TERM OUTCOME FOR THIS IMPLANT IS UNKNOWN AT PRESENT. THE RAPID EXCHANGE DELIVERY SYSTEM WILL ALLOW FOR PERFUSION AT AN AVERAGE RATE OF 2CC/MIN AT NOMINAL PRESSURE DURING THE 15-30 SECOND STENT DEPLOYMENT PROCEDURE ONLY. THE RAPID EXCHANGE STENT DELIVERY SYSTEM IS NOT INTENDED FOR USE AS A STAND ALONE PTCA PERFUSION CATHETER.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary