BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    PMA: P860019 · Supplement: S131 · Decision Jun 29, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70

    Basic Information

    Device Name
    Catheters, Transluminal Coronary Angioplasty, Percutaneous
    Trade Name
    SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
    PMA Number
    P860019
    Supplement Number
    S131
    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
    June 29, 1998
    Date Received
    October 3, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a modification of the SCIMED Ranger(TM) PTCA Catheter, with the primary difference being use of a new balloon material. The device, as modified, will be marketed under the trade name SCIMED(R) COYOTE(TM) Percutaneous Transluminal Angioplasty Coronary (PTCA) Catheter and is indicated for the balloon dilatation of coronary arteries or bypass graft stenoses for the prupose of improving myhocardial perfusion and (balloon models 2.5-4.0 mm only) the post-delivery expansion of balloon expandable stents.

    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