- Device
- Navistar DS, Celsius DS, EZ Steer DS Bi-directional non nav, EZ Steer Nav DS Bi-directional, Celsius FLTR Uni-directiona
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S062
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- 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.