BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P930029 · Supplement: S015 · Decision Oct 9, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    RF CONTACTR ABLATION CATHETER
    PMA Number
    P930029
    Supplement Number
    S015
    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
    October 9, 2001
    Date Received
    August 6, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ADDITION OF A SECONDARY DISTAL CURVE FEATURE CAPABLE OF DEFLECTIONS OF UP TO 135 DEGREES AND THE REMOVAL OF THE VARIABLE CURVE REACH FEATURE AND OTHER MINOR DESIGN CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RF CONTACTR ABLATION CATHETER AND IS INDICATED FOR USE WITH A MEDTRONIC RF POWER GENERATOR FOR THE INTERRUPTION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA FOR THE TREATMENT OF AV NODAL RE-ENTRANT TACHYCARDIA AND FOR CREATION OF COMPLETE AV BLOCK IN PATIENTS WITH A DIFFICULT TO CONTROL VENTRICULAR RESPONSE TO AN ATRIAL ARRHYTHMIA.

    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