- Device
- ThermoCool SmartTouch
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S125
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2022-02-01
- Decision code
- APPR
- Date received
- 2021-10-20
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for an extension of the ThermoCool SmartTouch (ST) and ThermoCool SmartTouch SF (STSF) finished device shelf life from one to three years.