- Device
- FlexAbility and FlexAbility SE Ablation Catheter
- Applicant
- ABBOTT MEDICAL
- PMA number
- P110016
- Supplement
- S076
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2021-05-18
- Decision code
- OK30
- Date received
- 2021-04-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to a resin as a result of transferring resin manufacturing from the current supplier manufacturing site in LaPorte, TX to a new supplier manufacturing site in Avon, OH.