- Device
- FlexAbility Ablation Catheter, FlexAbility Ablation Catheter Sensor Enabled
- Applicant
- ABBOTT MEDICAL
- PMA number
- P110016
- Supplement
- S078
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2021-09-22
- Decision code
- OK30
- Date received
- 2021-08-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a sterilization chamber (Chamber 5) at the Steris sterilization facility in Costa Rica.