PMA P990025S049
- Device
- NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S049
- Product code
- DRF
- Decision date
- 2017-08-10
- Classification
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Approval order statement
- Approval for a material change to the adhesive mixture used in the manufacture of BWI catheters and cables.
Current openFDA PMA Record#
- Device
- NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S049
- Product code
- DRF
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Decision date
- 2017-08-10
- Decision code
- APPR
- Date received
- 2016-06-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a material change to the adhesive mixture used in the manufacture of BWI catheters and cables.