- Device
- FlexAbility Ablation Catheter (FlexAbility) and FlexAbility Ablation Catheter, Sensor Enabled (FlexAbility SE)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P110016
- Supplement
- S077
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2021-06-25
- Decision code
- OK30
- Date received
- 2021-05-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate supplier for a spooled wire and electrode subassembly.