PMA
P130026: TACTICATH QUARTZ SET
FDA PMA · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation · St Jude Medical
Key facts
| PMA number | P130026 |
|---|---|
| Trade name | TACTICATH QUARTZ SET |
| Generic name | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
| Applicant | St Jude Medical |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | OAE |
| Approval date | Oct 24, 2014 |
| Docket number | 14M-1736 |
| Notice date | Nov 21, 2014 |
| Establishment registration | 2184149 |
| FEI number | 1000139754 |
At a glance
- 100–999 Supplements
- Aug 7, 2026 Latest supplement decision
- No Withdrawn
- Yes 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: