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

    Catheter, Coronary, Atherectomy

    PMA: P900056 · Supplement: S126 · Decision Sep 27, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Catheter, Coronary, Atherectomy
    Trade Name
    ROTABLATOR ROTALIONAL ATHERECTOMY SYSTEM
    PMA Number
    P900056
    Supplement Number
    S126
    Device Class
    FDA Class 3
    Product Code
    MCX
    Generic Name
    CATHETER, CORONARY, ATHERECTOMY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 27, 2013
    Date Received
    August 29, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    P050019/S0179/27/13 CAROTID WALLSTENT® MONORAIL® ENDOPROSTHESIS PGSOOOS CHILLI II® COOLED ABLATION CATHETER, MODEL8005 CIRCUCOOL PUMP, MODEL2104 TUBINGKIT, STERILE CABLES BOSTON SCIENTIFIC CORPORATION MAPLE GROVE MN 55311 USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.

    Classifications

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

    Product Code Device Name
    MCX Catheter, Coronary, Atherectomy