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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.
 
DeviceTHERMOCOOL 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
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Applicant
BIOSENSE WEBSTER, INC.
3333 diamond canyon rd.
diamond bar, CA 91765
PMA NumberP030031
Supplement NumberS034
Date Received06/20/2011
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/material
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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