- Device
- THERMOCOOL SMARTTOUCH® Uni-Directional Navigation Catheter, THERMOCOOL SMARTTOUCH® Bi-Directional Navigation Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P040036
- Supplement
- S085
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2021-09-07
- Decision code
- OK30
- Date received
- 2021-08-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional supplier to produce a thermocouple wire component.