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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTHERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER (D-1315-XX-S, D-1318-XX-S) AND THERMOCOOL SF UNI-DIRECTIONAL CATHETER
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP030031
Supplement NumberS034
Date Received06/30/2011
Decision Date12/21/2011
Product Code
OAE[ Registered Establishments with OAE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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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