- Device
- Dual Energy THERMOCOOL SMARTTOUCH SF™ System
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S141
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2026-07-01
- Decision code
- APPR
- Date received
- 2025-09-25
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- 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.