PMA P010068S049
- Device
- CELSIUS, CELSIUS FLTR, NAVISTAR DS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S049
- Product code
- OAD
- Decision date
- 2015-11-05
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- THE ADDITION OF AN ALTERNATE LOCATION FOR A PLASMA ETCHING PROCESS, IN ADDITION TO THE QUALIFICATION OF A NEWER EQUIPMENT MODEL FOR THAT SAME MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- CELSIUS, CELSIUS FLTR, NAVISTAR DS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S049
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2015-11-05
- Decision code
- OK30
- Date received
- 2015-10-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- THE ADDITION OF AN ALTERNATE LOCATION FOR A PLASMA ETCHING PROCESS, IN ADDITION TO THE QUALIFICATION OF A NEWER EQUIPMENT MODEL FOR THAT SAME MANUFACTURING PROCESS.