BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P990071 · Supplement: S040 · Decision May 8, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    CoolFlow Irrigation Tubing Set
    PMA Number
    P990071
    Supplement Number
    S040
    Device Class
    FDA Class 3
    Product Code
    LPB
    Generic Name
    Cardiac ablation percutaneous catheter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 8, 2019
    Date Received
    June 20, 2018
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the addition of a second source supplier for the CoolFlow Irrigation Tubing Set, which is a manufacturing site located at: Lake Region Medical, Inc.Venusa de Mexico S. de R.L. de C.V.1525 Calle Hertz Street Parque Industrial Antonio J. BermudezCiudad Juarez, Chihuahua 32470 Mexico

    Classifications

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

    Product Code Device Name
    LPB Cardiac Ablation Percutaneous Catheter