BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P970035 · Supplement: S031 · Decision Mar 1, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    S7 W/DISCRETE TECHNOLOGY(TM)OTW/RAPID EXCHANGE CORONARY STENT SYSTEM
    PMA Number
    P970035
    Supplement Number
    S031
    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
    March 1, 2002
    Date Received
    October 1, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO UPDATE THE MEDTRONIC AVE S7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEM LABELING TO INCLUDE 6-MONTH POST-PROCEDURE RESULTS FOR THE STUDY POPULATION.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary