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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.
 
DeviceDual Energy THERMOCOOL SMARTTOUCH SF™ System
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBiosense Webster, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP030031
Supplement NumberS141
Date Received09/25/2025
Decision Date07/01/2026
Product Codes OAD OAE QZI 
Docket Number FDA-7604
Notice Date 07/08/2026
Advisory Committee Cardiovascular
Clinical TrialsNCT06144632
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Dual Energy THERMOCOOL SMARTTOUCH SF™ System. This device is indicated for:Dual Energy THERMOCOOL SMARTTOUCH™ SF CatheterThe Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter and related accessory devices are indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible generator, for the treatment of:When using Radiofrequency (RF) energy Only:• Type I atrial flutter in patients age 18 or older.• Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems.• Drug refractory recurrent symptomatic persistent atrial fibrillation (defined as continuous atrial fibrillation that is sustained beyond 7 days but less than 1 year), refractory or intolerant to at least one Class I or III antiarrhythmic medicine, when used with compatible three-dimensional electroanatomic mapping systems.When using Pulsed Field (PF) energy:• Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems.The Dual Energy THERMOCOOL SMARTTOUCH™ SF Navigation Catheter provides a real-time measurement of contact force between the catheter tip and the heart wall, as well as location information when used with the CARTO™ 3 System.nGEN™ PumpThe nGEN™ Pump is a peristaltic pump designed to work with a compatible irrigation tubing set, either independently or with a compatible generator, to deliver irrigation solution to compatible irrigated catheter.Sterile Interface CableThis cable provides a means to connect a Biosense Webster electrophysiology catheter to the appropriate equipment. The cable may be reused subject to the cleaning and sterilization restrictions detailed in Instructions for Use.
Approval OrderApproval Order
Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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