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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTHERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER (D-1315-XX-S, D-1318-XX-S) AND THERMOCOOL SF UNI-DIRECTIONAL CATHETER
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantBIOSENSE WEBSTER, INC.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP030031
Supplement NumberS034
Date Received06/20/2011
Decision Date12/21/2011
Product Codes OAD OAE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order 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.
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