PMA
P190015: TREO® Abdominal Stent-Graft System
FDA PMA · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT · Bolton Medical, Inc.
Key facts
| PMA number | P190015 |
|---|---|
| Trade name | TREO® Abdominal Stent-Graft System |
| Generic name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Applicant | Bolton Medical, Inc. |
| Owner/operator | BOLTON MEDICAL, INC. |
| Product code | MIH |
| Approval date | May 4, 2020 |
| Docket number | 20M-1311 |
| Notice date | May 7, 2020 |
| Establishment registration | 2247858 |
| FEI number | 1000135961 |
At a glance
- 10–99 Supplements
- Jun 18, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 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: