- Device
- THERMOCOOL SMARTTOUCH SF Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P040036
- Supplement
- S098
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2024-05-24
- Decision code
- APPR
- Date received
- 2024-04-26
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for changes to the Instructions for Use for the THERMOCOOL SMARTTOUCH Catheter and THERMOCOOL SMARTTOUCH SF Catheter to include the updated clinical data results from the final clinical study report for the Zero/Low Fluoroscopy Workflow