- Device
- Thermocool SF NAV, Celsius Thermocool, EZ Steer Thermocool, EZ Steer Thermocool Bi-Directional, and Navistar Thermocool
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S112
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2021-02-02
- Decision code
- OK30
- Date received
- 2021-01-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of an automated dimensional inspection process for the ring spacing, tip length, and shaft outer diameter.