- Device
- NaviStar Catheter, NaviStar RMT Catheter, EZ Steer Nav Catheter, Interface Cables
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S071
- Product code
- DRF
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Decision date
- 2023-06-12
- Decision code
- OK30
- Date received
- 2023-05-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a new ethylene oxide sterilization cycle at the Sterigenics, Santa Teresa, NM facility.