BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P960016 · Supplement: S019 · Decision Sep 24, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    SAFIRE CARDIAC ABLATION SYSTEM
    PMA Number
    P960016
    Supplement Number
    S019
    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
    September 24, 2007
    Date Received
    August 7, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING MODIFICATIONS THAT ALLOWS: 1) THE IBI-1500T6 AND T9 CARDIAC ABLATION GENERATORS (EQUIPPED WITH TEMPERATURE MONITORING) TO BE USED WITH THE SAFIRE BI-DIRECTIONAL ABLATION CATHETER AND 2) THE EXTENSION CABLES (PREVIOUSLY APPROVED UNDER P960016/S016 FOR USE WITH THE IBI-1500T6) BE USED WITH THE IBI-1500 T9 RF GENERATOR.

    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