PMA
N16837: ARTEGRAFT{TM} AND REINFORCED ARTEGRAFT{TM}
FDA PMA · Tissue graft of 6mm and greater · LeMaitre Vascular, Inc.
Key facts
| PMA number | N16837 |
|---|---|
| Trade name | ARTEGRAFT{TM} AND REINFORCED ARTEGRAFT{TM} |
| Generic name | Tissue graft of 6mm and greater |
| Applicant | LeMaitre Vascular, Inc. |
| Owner/operator | LEMAITRE VASCULAR, INC. |
| Product code | LXA |
| Approval date | Aug 1, 1979 |
| Establishment registration | 1220948 |
| FEI number | 1220948 |
At a glance
- 10–99 Supplements
- Sep 4, 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- No Withdrawn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: