PMA P990025S001
- Device
- NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S001
- Product code
- DRF
- Decision date
- 2000-09-28
- Classification
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Approval order statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT BIOSENSE WEBSTER, INC. ,IRWINDALE, CALIFORNIA.
Current openFDA PMA Record#
- Device
- NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S001
- Product code
- DRF
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Decision date
- 2000-09-28
- Decision code
- APPR
- Date received
- 2000-07-31
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT BIOSENSE WEBSTER, INC. ,IRWINDALE, CALIFORNIA.