PMA P990025S005
- Device
- NAVISTAR DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S005
- Product code
- DRF
- Decision date
- 2002-11-13
- Classification
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Approval order statement
- APPROVAL FOR THE STERILIZATION FACILITY LOCATED AT COSMED OF CALIFORNIA, SAN DIEGO, CALIFORNIA.
Current openFDA PMA Record#
- Device
- NAVISTAR DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S005
- Product code
- DRF
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Decision date
- 2002-11-13
- Decision code
- APPR
- Date received
- 2002-04-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Approval order statement
- APPROVAL FOR THE STERILIZATION FACILITY LOCATED AT COSMED OF CALIFORNIA, SAN DIEGO, CALIFORNIA.