- Device
- EZ Steer Non- Navigational 8mm (DS) ; EZ Steer DS ; EZ Steer Non-Navigational 4mm (TC) & (THR) ; Celsius 4mm Bi-Dir T ;
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S066
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2017-07-27
- Decision code
- OK30
- Date received
- 2017-06-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of the 6-Up Reflow Machine with Recipe Control for Reflow process on all Biosense Webster quad lumen catheter tips at Irwindale