PMA P010068S037
- Device
- CELSIUS FLTR CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S037
- Product code
- OAD
- Decision date
- 2013-11-26
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- CHANGE TO THE OVEN PARAMETERS IN THE TIP REFLOW PROCESS AND IMPLEMENTATIONOF A NEW INSPECTION.
Current openFDA PMA Record#
- Device
- CELSIUS FLTR CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S037
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2013-11-26
- Decision code
- OK30
- Date received
- 2013-10-18
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE TO THE OVEN PARAMETERS IN THE TIP REFLOW PROCESS AND IMPLEMENTATIONOF A NEW INSPECTION.