PMA P110016S090
- Device
- FlexAbility™ Ablation Catheter, Sensor Enabled™
- Applicant
- ABBOTT MEDICAL
- PMA number
- P110016
- Supplement
- S090
- Product code
- OAD
- Decision date
- 2025-05-06
- Classification
- Cardiovascular
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- automation of the electrode ring and wire subassembly manufacturing process
Current openFDA PMA Record#
- Device
- FlexAbility™ Ablation Catheter, Sensor Enabled™
- Applicant
- ABBOTT MEDICAL
- PMA number
- P110016
- Supplement
- S090
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2025-05-06
- Decision code
- OK30
- Date received
- 2025-04-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- automation of the electrode ring and wire subassembly manufacturing process