- Device
- Celsius FLTR (Flutter) Catheter, Celsius Electrophysiology Catheter, Webster Electrophysiology Catheter EZ Steer DS Bi-D
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S081
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2021-07-09
- Decision code
- OK30
- Date received
- 2021-06-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an electronic vision sensor to the device packaging process.