- Device
- Therapy Cool Path Duo, Safire BLU Duo, Cool Path Duo, Safire Duo, Therapy Cool Path Duo SP, Safire BLU Duo SP and Therap
- Applicant
- ABBOTT MEDICAL
- PMA number
- P110016
- Supplement
- S070
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2020-11-02
- Decision code
- APPR
- Date received
- 2020-07-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software and cybersecurity updates to the Ampere Ablation Generator.