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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 SF UNI-DIRECTIONAL NAVIGATION CATHETER; THERMOCOOL SMARTTOUCH SF BI-DIRECTIONAL NAVIGATION CATHETE
Generic NameCardiac ablation percutaneous catheter
ApplicantBIOSENSE WEBSTER, INC.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP030031
Supplement NumberS072
Date Received02/01/2016
Decision Date08/11/2016
Product Codes LPB OAD OAE 
Advisory Committee Cardiovascular
Clinical TrialsNCT02359890
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 THERMOCOOL SMARTTOUCH® SF Catheters, part numbers D-1347-XX-S and D-1348-XX-S, 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; and 2) Drug refractory recurrent symptomatic paroxysmalatrial fibrillation, when used with compatible three dimensional electroanatomic mapping systems. The THERMOCOOL SMARTTOUCH® SF 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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