PMA
P040002: ENDOLOGIX POWERLINK SYSTEM
FDA PMA · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT · Endologix, LLC
Key facts
| PMA number | P040002 |
|---|---|
| Trade name | ENDOLOGIX POWERLINK SYSTEM |
| Generic name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Applicant | Endologix, LLC |
| Owner/operator | Endologix LLC |
| Product code | MIH |
| Approval date | Oct 29, 2004 |
| Docket number | 04M-0533 |
| Notice date | Dec 8, 2004 |
| Establishment registration | 3011063223 |
| FEI number | 3011063223 |
At a glance
- 10–99 Supplements
- Sep 27, 2024 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- No Withdrawn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: