PMA P010068S065
- Device
- CELSIUS, NAVISTAR and EZ STEER
- Applicant
- Biosense Webster, Inc.
- Product code
- OAD
- Decision date
- 2021-09-22
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Approval for updated labeling, including modified warnings and directions for use.
Current openFDA PMA Record#
- Device
- CELSIUS, NAVISTAR and EZ STEER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S065
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2021-09-22
- Decision code
- APPR
- Date received
- 2021-05-17
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updated labeling, including modified warnings and directions for use.