PMA P990025S008
- Device
- NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S008
- Product code
- DRF
- Decision date
- 2003-02-04
- Classification
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Approval order statement
- APPROVAL FOR ESTABLISHING AND EXTENDING PACKAGE AND PRODUCT SHELF LIVES.
Current openFDA PMA Record#
- Device
- NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S008
- Product code
- DRF
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Decision date
- 2003-02-04
- Decision code
- APPR
- Date received
- 2003-01-02
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR ESTABLISHING AND EXTENDING PACKAGE AND PRODUCT SHELF LIVES.