BEUDAMED
    FDA PMA FDA Class 2 30-Day Notice Accepted 🇺🇸 United States

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    PMA: P790017 · Supplement: S088 · Decision Aug 29, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70

    Basic Information

    Device Name
    Catheters, Transluminal Coronary Angioplasty, Percutaneous
    Trade Name
    SPRINTER OVER THE WIRE (OTW) & SPRINTER MULTI-EXCHANGE (MX2) BALLOON DILATATION CATHETER
    PMA Number
    P790017
    Supplement Number
    S088
    Device Class
    FDA Class 2
    Product Code
    LOX
    Generic Name
    Catheters, transluminal coronary angioplasty, percutaneous
    Regulation Number
    870.5100
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 29, 2007
    Date Received
    July 30, 2007
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDING ISOTRON IRELAND, ONE OF MEDTRONIC?S APPROVED CONTRACT ETHYLENE OXIDE (ETO) STERILIZATION FACILITIES, TO RECEIVE, STORE, AND PREPARE BIOLOGICAL INDICATORS FOR ROUTINE STERILIZATION CYCLES AND TO COMPLETE VIABILITY TESTING.

    Classifications

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

    Product Code Device Name
    LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous