PMA P990025S055
- Device
- Navi-Star Diagnostic/Ablation Deflectable Tip Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S055
- Product code
- DRF
- Decision date
- 2017-10-17
- Classification
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Approval order statement
- Transfer the location of activities associated with receiving, inspection, pre-release and final release.
Current openFDA PMA Record#
- Device
- Navi-Star Diagnostic/Ablation Deflectable Tip Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S055
- Product code
- DRF
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Decision date
- 2017-10-17
- Decision code
- OK30
- Date received
- 2017-10-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer the location of activities associated with receiving, inspection, pre-release and final release.