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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 Catheter
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBIOSENSE WEBSTER, INC.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP030031
Supplement NumberS100
Date Received12/23/2019
Decision Date09/30/2020
Product Code OAD 
Docket Number 20M-2098
Notice Date 10/13/2020
Advisory Committee Cardiovascular
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Biosense Webster THERMOCOOL SMARTTOUCH® SF 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) Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. 3) Drug refractory recurrent symptomatic persistent atrial fibrillation (defined as continuous atrial fibrillation that is sustained beyond 7 days but less than 1 year); and refractory or intolerant to at least one Class I or III antiarrhythmic medicine, 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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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