PMA P010068S018
- Device
- NAVISTAR (4MM, DS, THERMOCOOL AND RMT)
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S018
- Product code
- OAD
- Decision date
- 2009-12-14
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- 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 (4MM, DS, THERMOCOOL AND RMT)
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S018
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- 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.