PMA P010068S041
- Device
- CELSIUS FLTR BI-DIRECTIONAL CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S041
- Product code
- OAD
- Decision date
- 2014-09-12
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- MODIFICATION OF A PROCESS USED TO MANUFACTURE THE CATHETERS QUAD LUMEN SOFT TIP.
Current openFDA PMA Record#
- Device
- CELSIUS FLTR BI-DIRECTIONAL CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S041
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2014-09-12
- Decision code
- OK30
- Date received
- 2014-08-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATION OF A PROCESS USED TO MANUFACTURE THE CATHETERS QUAD LUMEN SOFT TIP.