- Device
- EZ Steer Thermocool Navigation, EZ Steer Thermocool Bi-Directional Catheter, Thermocool SF Nav Bi-Directional Catheter,
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S101
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2020-02-26
- Decision code
- OK30
- Date received
- 2020-01-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Line 13 transfer and addition of new Slim Line Dryer