BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    PMA: P190008 · Decision Nov 21, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Drug-Coated Peripheral Transluminal Angioplasty Catheter
    Trade Name
    IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
    PMA Number
    P190008
    Device Class
    FDA Class 3
    Product Code
    PRC
    Generic Name
    Drug-coated peripheral transluminal angioplasty catheter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 21, 2019
    Date Received
    April 3, 2019
    Expedited Review
    N
    Docket Number
    19M-5534

    Advisory Committee Statement

    Approval for the IN.PACT AV Paclitaxel-coated PTA Balloon Catheter. The device is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, for the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae with reference vessel diameters of 4 to 12 mm.

    Classifications

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

    Product Code Device Name
    PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter