- Device
- FlexAbility and FlexAbility SE Ablation Catheter, FlexAbility Cables Sensor Enabled
- Applicant
- ABBOTT MEDICAL
- PMA number
- P110016
- Supplement
- S069
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2020-06-04
- Decision code
- OK30
- Date received
- 2020-05-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of parametric release as part of the sterilization process at the Midwestern Sterilization Corporation facility.