- Device
- NAVISTAR Electrophysiology Catheter, EZ Steer NAV Bi-Directional Electrophysiology Catheter, NAVISTAR RMT Electrophysiol
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S073
- Product code
- DRF
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Decision date
- 2024-11-20
- Decision code
- OK30
- Date received
- 2024-10-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an additional supplier for electromagnetic interference (EMI) shield components