BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Stent, Coronary

    PMA: P130030 · Supplement: S043 · Decision Aug 31, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    Rebel Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire)
    PMA Number
    P130030
    Supplement Number
    S043
    Device Class
    FDA Class 3
    Product Code
    MAF
    Generic Name
    STENT, CORONARY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 31, 2017
    Date Received
    August 4, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Update the BSC2000-2 cycle conducted in Chamber 2 at the BSC Coventry, RI facility with new Programmable Logic Controller (PLC) software, an additional vacuum pump booster, and a new validation documentation structure used to support the system.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary