- Device
- VISITAG SURPOINT External Processing Unit (EPU)
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S110
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2021-11-12
- Decision code
- APPR
- Date received
- 2020-11-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes to the Indications for Use and the Instructions for Use (IFU) for the VISITAG SURPOINT External Processing Unit (EPU).