BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P990071 · Supplement: S055 · Decision Jan 24, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    SmartAblate™ Irrigation Tubing Set
    PMA Number
    P990071
    Supplement Number
    S055
    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
    January 24, 2023
    Date Received
    June 24, 2022
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for alternate components; changes in sterilization monitoring; an alternate physical manufacturing site at Harmac Medical Products, Inc. H3 de Tijuana S. de RL de CV Calle Maquiladoras No. 320-A Col. Ciudad Industrial Nueva Tijuana CP 22500 Mexico; and an alternate sterilization site at STERIS AST, 1000 Sarah Place, Ontario, CA 91761 USA.

    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