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

    Catheter, Coronary, Atherectomy

    PMA: P980037 · Supplement: S041 · Decision Mar 5, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Catheter, Coronary, Atherectomy
    Trade Name
    ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM
    PMA Number
    P980037
    Supplement Number
    S041
    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
    March 5, 2014
    Date Received
    February 3, 2014
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    MODIFICATION TO CHANGE THE CURRENT MANUAL METHOD OF QUANTIFYING THE AMOUNT OF BACTERIAL ENDOTOXINS PRESENT TO USING AN AUTOMATED INSTRUMENT. ADDITIONALLY, THE NUMBER OF SAMPLES COLLECTED WILL BE CHANGED TO THREE SAMPLES PER STERILE LOAD, TESTED ON A POOLED BASIS AND WITH EXPLICIT EXTRACTION INSTRUCTIONS.

    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