- Device
- Celsius ThermoCool Electrophysiology Catheter, EZ Steer ThermoCool Bi-Directional Electrophysiology Catheter, EZ Steer T
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S121
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2021-07-09
- Decision code
- OK30
- Date received
- 2021-06-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an electronic vision sensor to the device packaging process.