- Device
- Celsius RMT ThermoCool Catheter, Celsius ThermoCool Catheter, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Cath
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S116
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2021-04-28
- Decision code
- OK30
- Date received
- 2021-03-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New ethylene oxide (EO) sterilization cycle (J&J Consolidated Cycle 1) at the Steris IsoMedix Services (Steris SD) facility in San Diego, CA.