PMA P990025S003
- Device
- NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER\
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S003
- Product code
- DRF
- Decision date
- 2001-01-11
- Classification
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Approval order statement
- CHANGE TO THE POLYMERIC MIXTURE USED TO MANUFACTURE THE CATHETER'S TIP. THE CHANGE IS INTENDED TO STANDARDIZE PROCESSES ACROSS THE NAVI-STAR PRODUCT LINE.
Current openFDA PMA Record#
- Device
- NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER\
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S003
- Product code
- DRF
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Decision date
- 2001-01-11
- Decision code
- OK30
- Date received
- 2000-12-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE POLYMERIC MIXTURE USED TO MANUFACTURE THE CATHETER'S TIP. THE CHANGE IS INTENDED TO STANDARDIZE PROCESSES ACROSS THE NAVI-STAR PRODUCT LINE.