PMA P990025S048
- Device
- NAVI-STAR and EZ Steer Nav Bi-Directional Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S048
- Product code
- DRF
- Decision date
- 2016-04-25
- Classification
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Approval order statement
- Implementation of a new pouch sealer to be used in the approved facility to seal the primary pouch for the catheter product codes.
Current openFDA PMA Record#
- Device
- NAVI-STAR and EZ Steer Nav Bi-Directional Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S048
- Product code
- DRF
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Decision date
- 2016-04-25
- Decision code
- OK30
- Date received
- 2016-03-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a new pouch sealer to be used in the approved facility to seal the primary pouch for the catheter product codes.