BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    PMA: P190008 · Supplement: S010 · Decision Feb 18, 2021
    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 (PTA) Balloon Catheter
    PMA Number
    P190008
    Supplement Number
    S010
    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
    February 18, 2021
    Date Received
    January 19, 2021
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the revised study inclusion and exclusion criteria, revised study milestone, and clarification-based updates to the base protocol.

    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