BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    PMA: P810046 · Supplement: S182 · Decision Jan 27, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70

    Basic Information

    Device Name
    Catheters, Transluminal Coronary Angioplasty, Percutaneous
    Trade Name
    ACS TX 2000 VP CORONARY DILATATION CATHETER CAHTETERS
    PMA Number
    P810046
    Supplement Number
    S182
    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
    Approved
    Decision Code
    APPR
    Decision Date
    January 27, 1998
    Date Received
    November 24, 1997
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N
    Docket Number
    N

    Advisory Committee Statement

    Approval for an E-beam sterilization process validation protocol and a manufacturing site located at Guidant Corporation, Advanced Cardiovascular Systems, 26531 Ynez Rd., Temecula, CA 92591-4628.

    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