PMA P990025S022
- Device
- NAVISTAR THERMOCOOL AND NAVISTAR RMT THERMOCOOL CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S022
- Product code
- LPB
- Decision date
- 2009-12-14
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- APPROVAL FOR CHANGES TO THE CATHETER IFUS TO ALLOW FOR ADDITIONAL COMPATIBILITY WITH THE CARTO 3 SYSTEMS.
Current openFDA PMA Record#
- Device
- NAVISTAR THERMOCOOL AND NAVISTAR RMT THERMOCOOL CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S022
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2009-12-14
- Decision code
- APPR
- Date received
- 2009-10-09
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO THE CATHETER IFUS TO ALLOW FOR ADDITIONAL COMPATIBILITY WITH THE CARTO 3 SYSTEMS.