PMA P010068S057
- Device
- Celsius DS Electrophysiology Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S057
- Product code
- OAD
- Decision date
- 2018-07-30
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Addition of a new sealer for the sterile pouch.
Current openFDA PMA Record#
- Device
- Celsius DS Electrophysiology Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S057
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2018-07-30
- Decision code
- OK30
- Date received
- 2018-07-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new sealer for the sterile pouch.