PMA
P150002: INCRAFT(R) AAA STENT GRAFT SYSTEM
FDA PMA · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT · Cordis US Corporation
Key facts
| PMA number | P150002 |
|---|---|
| Trade name | INCRAFT(R) AAA STENT GRAFT SYSTEM |
| Generic name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Applicant | Cordis US Corporation |
| Owner/operator | Cordis US Corp. |
| Product code | MIH |
| Approval date | Nov 27, 2018 |
| Docket number | 18M-4580 |
| Notice date | Dec 6, 2018 |
| Establishment registration | 1016427 |
| FEI number | 1016427 |
At a glance
- 10–99 Supplements
- May 15, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: