PMA
P220013: TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency C
FDA PMA · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation · ABBOTT MEDICAL
Key facts
| PMA number | P220013 |
|---|---|
| Trade name | TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency C |
| Generic name | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
| Applicant | ABBOTT MEDICAL |
| Product code | OAE |
| Approval date | May 18, 2023 |
| Docket number | 23M-2395 |
| Notice date | Jun 14, 2023 |
| FEI number | 3005334138 |
At a glance
- 10–99 Supplements
- Sep 22, 2026 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: