PMA supplement
P220013 S028: TactiFlex™ Duo Ablation Catheter, Sensor Enabled™ (A-TFDM-D, A-TFDM-F, A-TFDM-J, A-TFDM-DD, A-TFDM-DF, A-TFDM-FF, A-TFDM
FDA PMA supplement · Panel Track · ABBOTT MEDICAL
Key facts
| Original PMA | P220013 |
|---|---|
| Supplement number | S028 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | TactiFlex™ Duo Ablation Catheter, Sensor Enabled™ (A-TFDM-D, A-TFDM-F, A-TFDM-J, A-TFDM-DD, A-TFDM-DF, A-TFDM-FF, A-TFDM |
| Generic name | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
| Applicant | ABBOTT MEDICAL |
| Product code | OAE |
| Received date | Mar 2, 2026 |
| Decision date | Sep 4, 2026 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: