- Device
- TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P220013
- Supplement
- S018
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2025-04-11
- Decision code
- OK30
- Date received
- 2025-03-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a modification to the magnetic sensor manufacturing process to support more flexible sourcing