BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P970061 · Supplement: S014 · Decision Feb 15, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    SCIMEN RADIUS STENT WITH MONORAIL DELIVERY SYSTEM
    PMA Number
    P970061
    Supplement Number
    S014
    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
    February 15, 2002
    Date Received
    January 8, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MINOR LABELING CHANGES TO THE PACKAGE LABELING AND THE "DIRECTIONS FOR USE" MANUAL FOR THE RADIUS CORONARY STENT SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SCIMED RADIUS STENT WITH MONORAIL DELIVERY SYSTEM AND IS INDICATED FOR USE IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO NATIVE CORONARY ARTERY AND SAPHENOUS VEIN BYPASS GRAFT LESIONS (LENGTH < 30 MM) WITH A REFERENCE VESSEL DIAMETER RANGING FROM 2.75 TO 4.25 MM AND IS INTENDED TO IMPROVE CORONARY LUMINAL DIAMETER.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary