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. |
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Device | THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER,THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER,THERM |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P030031 |
Supplement Number | S053 |
Date Received | 06/17/2013 |
Decision Date | 02/11/2014 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH 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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