- Device
- THERMOCOOL SMARTTOUCH® SF Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S142
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2026-09-02
- Decision code
- APPR
- Date received
- 2026-03-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- The Biosense Webster THERMOCOOL SMARTTOUCH™ SF Uni-/Bi-DirectionalNavigation 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:• Type I atrial flutter in patients age 18 or older.• Recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems, as an alternative to antiarrhythmic drug therapy, or as an initial rhythm control strategy.• 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.The Biosense Webster THERMOCOOL SMARTTOUCH™ SF Uni-/Bi-DirectionalNavigation 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.