PMA P990025S065
- Device
- CELSIUS and EZ STEER
- Applicant
- Biosense Webster, Inc.
- Product code
- DRF
- Decision date
- 2021-09-22
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Approval order statement
- Approval for updated labeling, including modified warnings and directions for use.
Current openFDA PMA Record#
- Device
- CELSIUS and EZ STEER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S065
- Product code
- DRF
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- 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.