PMA P950005S054
- Device
- CELSIUS FLUTTERS, CELSIUS, CELSIUS RMT, EZ STEER 4MM NON-NAV, EZ STEER DS, CELSIUS FLUTTERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S054
- Product code
- LPB
- Decision date
- 2014-11-18
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- APPROVAL FOR CHANGES TO YOUR SOLDER IN ORDER TO COMPLY WITH THE EU ROHS DIRECTIVE.
Current openFDA PMA Record#
- Device
- CELSIUS FLUTTERS, CELSIUS, CELSIUS RMT, EZ STEER 4MM NON-NAV, EZ STEER DS, CELSIUS FLUTTERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S054
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- 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.