BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    PMA: P190008 · Supplement: S038 · Decision Jan 30, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    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
    Supplement Number
    S038
    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
    January 30, 2026
    Date Received
    April 7, 2025
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    a visual system with a reticulate as a manufacturing aid during the catheter subassembly welding manufacturing step to aid in ensuring proper overlap between two of the device components

    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