PMA P010068S036
- Device
- CELSIUS FLTR CATHER UNIDIRECTIONAL,CELSIUS FLTR CATHETER BIDIRECTIONAL
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S036
- Product code
- OAD
- Decision date
- 2014-01-22
- 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 MANUFACTURING AND DESIGN CHANGES TO THE CATHETER TIP.
Current openFDA PMA Record#
- Device
- CELSIUS FLTR CATHER UNIDIRECTIONAL,CELSIUS FLTR CATHETER BIDIRECTIONAL
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S036
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2014-01-22
- Decision code
- APPR
- Date received
- 2013-11-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MANUFACTURING AND DESIGN CHANGES TO THE CATHETER TIP.