- Device
- FlexAbility Ablation Catheter (Flex) and FlexAbility Ablation Catheter, Sensor Enabled (Flex SE)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P110016
- Supplement
- S093
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2026-04-09
- Decision code
- OK30
- Date received
- 2026-03-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternative supplier for the Flex Tip subassembly (Flex Tip)