- Device
- TactiFlex™ Ablation Catheter, Sensor Enabled™ (A-TFSE-D; A-TFSE-F; A-TFSE-J; A-TFSE-DD; A-TFSE-DF; A-TFSE-FF; A-TFSE-FJ;
- Applicant
- ABBOTT MEDICAL
- PMA number
- P220013
- Supplement
- S029
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2026-05-15
- Decision code
- OK30
- Date received
- 2026-04-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- new equipment for the implementation of an automated inspection process for catheter assembly and electrical testing