PMA supplement
P150002 S008: INCRAFT(R) AAA STENT GRAFT SYSTEM
FDA PMA supplement · Normal 180 Day Track No User Fee · Cordis US Corporation
Key facts
| Original PMA | P150002 |
|---|---|
| Supplement number | S008 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - PAS |
| Trade name | INCRAFT(R) AAA STENT GRAFT SYSTEM |
| Generic name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Applicant | Cordis US Corporation |
| Product code | MIH |
| Received date | Mar 31, 2020 |
| Decision date | Sep 23, 2020 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: