BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P020009 · Supplement: S017 · Decision Mar 9, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (MONORAIL, MR AND OVER-THE-WIRE, OTW)
    PMA Number
    P020009
    Supplement Number
    S017
    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 9, 2005
    Date Received
    October 25, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO LABELING CONTAINED IN THE WARNINGS/ PRECAUTIONS SECTIONS OF THE DIRECTIONS FOR USE (DFU) AND PATIENT GUIDES BASED UPON UPDATED SAFETY INFORMATION RELATED TO MAGNETIC RESONANCE IMAGING (MRI) PERFORMED AT 3 TESLA.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary