BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P030031 · Supplement: S025 · Decision Dec 21, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46

    Basic Information

    Device Name
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
    Trade Name
    THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER (D-1313-XX-S, D-1317-XX-S) AND THERMOCOOL SF BI-DIRECTIONAL CATHETER
    PMA Number
    P030031
    Supplement Number
    S025
    Device Class
    FDA Class 3
    Product Code
    OAD
    Generic Name
    catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 21, 2011
    Date Received
    January 15, 2010
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING DEVICE 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);4) MODIFIED TIP ELECTRODE MATERIAL (FROM 90% PLATINUM/10% IRIDIUM TO 80% PALLADIUM/20% PLATINUM); AND 5) UPDATE STOCKERT 70 RF GENERATOR SOFTWARE (VL.035 TO VL.037). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES BI-DIRECTIONAL CARTO XP THERMOCOOL SF NAY CATHETER, BI-DIRECTIONAL CARTO 3 THERMOCOOL SF NAY CATHETER, AND BIDIRECTIONALTHERMOCOOL SF CATHETER AND IS INDICATED FOR:THE BIOSENSE WEBSTER THERMOCOOL SF NAV DIAGNOSTIC/ ABLATION DEFLECTABLE TIP CATHETER AND RELATED ACCESSORY DEVICES ARE INDICATED FOR CATHETER BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATING AND RECORDING) AND, WHEN USED WITH A COMPATIBLE RF GENERATOR, FOR THE TREATMENT OF 1) TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER; AND 2) 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 SYSTEMS. THE BIOSENSE WEBSTER THERMOCOOL SF DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER ANDRELATED ACCESSORIES ARE INDICATED FOR USE IN CATHETER-BASED CARDIAC ELECTROPHYSIOLOGICALMAPPING (STIMULATING AND RECORDING) AND, WHEN USED WITH A COMPATIBLE RF GENERATOR, FOR THETREATMENT 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
    OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter