- Device
- Celsius, Celsius RMT, EZ Steer Bi-directional non nav
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S077
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2021-04-07
- Decision code
- APPR
- Date received
- 2021-03-02
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the addition of warnings from other catheter lines and the clarification of existing warnings and instructions.