- Device
- EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool C
- Applicant
- Biosense Webster, Inc.
- PMA number
- P040036
- Supplement
- S086
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2021-09-22
- Decision code
- APPR
- Date received
- 2021-08-23
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to add an alternate sterilization site.