PMA P010068S043
- Device
- NAVISTAR DS, CELSIUS DS, EZ STEER NAV DS, NAVISTAR RMT DS, CELSIUS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S043
- Product code
- OAD
- Decision date
- 2014-11-18
- 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 YOUR SOLDER IN ORDER TO COMPLY WITH THE EU ROHS DIRECTIVE.
Current openFDA PMA Record#
- Device
- NAVISTAR DS, CELSIUS DS, EZ STEER NAV DS, NAVISTAR RMT DS, CELSIUS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S043
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2014-11-18
- Decision code
- APPR
- Date received
- 2014-09-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGES TO YOUR SOLDER IN ORDER TO COMPLY WITH THE EU ROHS DIRECTIVE.