PMA P990025S006
- Device
- NAVISTAR AND CELSIUS DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S006
- Product code
- DRF
- Decision date
- 2003-04-22
- Classification
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Approval order statement
- APPROVAL FOR CHANGES IN THE STERILIZATION CYCLE PARAMETERS (FROM CONVENTIONAL ETHYLENE OXIDE PROCESSING TO EO EXPRESS).
Current openFDA PMA Record#
- Device
- NAVISTAR AND CELSIUS DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S006
- Product code
- DRF
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Decision date
- 2003-04-22
- Decision code
- APPR
- Date received
- 2002-06-07
- Supplement type
- Real-Time Process
- Supplement reason
- Other
- Approval order statement
- APPROVAL FOR CHANGES IN THE STERILIZATION CYCLE PARAMETERS (FROM CONVENTIONAL ETHYLENE OXIDE PROCESSING TO EO EXPRESS).