- Device
- TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency C
- Applicant
- ABBOTT MEDICAL
- PMA number
- P220013
- Supplement
- S030
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2026-07-23
- Decision code
- APPR
- Date received
- 2026-04-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for firmware updates for the Current™ PFA Generator and compatible accessories