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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 SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER,THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER,THERM
Generic NameCardiac ablation percutaneous catheter
ApplicantBIOSENSE WEBSTER, INC.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP030031
Supplement NumberS053
Date Received06/17/2013
Decision Date02/11/2014
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ADDITION OF FORCE SENSING TECHNOLOGY TO THE CATHETER TIP.THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THERMOCOOL SMARTTOUCH CATHETER AND IS INDICATED FOR:THE BIOSENSE WEBSTER THERMOCOOL SMARTTOUCH NAVIGATION 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;2) RECURRENT DRUG/DEVICE REFRACTORY SUSTAINED MONOMORPHIC VENTRICULAR TACHYCARDIA(VT) DUE TO PRIOR MYOCARDIAL INFARCTION (MI) IN ADULTS; AND3) DRUG REFRACTORY RECURRENT SYMPTOMATIC PAROXYSMAL ATRIAL FIBRILLATION, WHEN USED WITH COMPATIBLE THREE-DIMENSIONAL ELECTROANATOMIC MAPPING SYSTEMS.THE THERMOCOOL SMARTTOUCH NAVIGATION CATHETER PROVIDES A REAL-TIME MEASUREMENT OF CONTACT FORCE BETWEEN THE CATHETER TIP AND HEART WALL, AS WELL AS LOCATION INFORMATION WHEN USED WITH CARTO 3 NAVIGATION SYSTEM.
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