BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

    PMA: P990071 · Supplement: S013 · Decision Dec 21, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61

    Basic Information

    Device Name
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
    Trade Name
    THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER (D-1315-XX-S, D-1318-XX-S) AND THERMOCOOL SF UNI-DIRECTIONAL CATHETER
    PMA Number
    P990071
    Supplement Number
    S013
    Device Class
    FDA Class 3
    Product Code
    OAE
    Generic Name
    Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 21, 2011
    Date Received
    June 20, 2011
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING MODIFICATIONS: 1) REDUCED RECOMMENDED SALINE FLOW RATE (REDUCE BY ~50%; 2) INCREASE IN NUMBER OF IRRIGATION HOLES (FROM 6 TO 56); 3) DECREASE IN SIZE OF IRRIGATION HOLES (FROM 0.016¿ TO 0.0035¿ DIAMETER); AND 4) MODIFIED TIP ELECTRODE MATERIAL (FROM 90% PLATINUM/10% IRIDIUM TO 80% PALLADIUM/20% PLATINUM).THE DEVICE, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES UNI-DIRECTIONAL CARTO XP THERMOCOOL SF NAV CATHETER, UNI-DIRECTIONAL CARTO 3 THERMOCOOL SF NAV CATHETER, AND UNI-DIRECTIONAL THERMOCOOL SF CATHETER AND IS INDICATED FOR CATHETER BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATING AND RECORDING) AND, WHEN USED WITH A COMPATIBLE RT GENERATOR, FOR THE TREATMENT OF: A) TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER; B) DRUG REFRACTORY RECURRENT SYMPTOMATIC PAROXYSMAL ATRIAL FIBRILLATION, WHEN USED WITH COMPATIBLE THREE-DIMENSIONAL ELECTROANATOMIC MAPPING SYSTEMS. THE THERMOCOOL SF NAV DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER PROVIDES LOCATION INFORMATION WHEN USED WITH COMPATIBLE CARTO EP NAVIGATION SSYTEMS. THE BIOSENSE WEBSTER THERMOCOOL SF DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER AND RELATED ACCESSORIES ARE INDICATED FOR USE IN CATHETER-BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATING AND RECORDING) AND, WHEN USED WITH A COMPATIBLE RF GENERATOR, FOR THE TREATMENT OF TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER.

    Classifications

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

    Product Code Device Name
    OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation