PMA supplement
P020018 S040: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT
FDA PMA supplement · Panel Track · Cook, Inc.
Key facts
| Original PMA | P020018 |
|---|---|
| Supplement number | S040 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT |
| Generic name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Applicant | Cook, Inc. |
| Product code | MIH |
| Received date | Oct 7, 2011 |
| Decision date | Apr 4, 2012 |
| Docket number | 12M-0371 |
| Notice date | Apr 17, 2012 |
At a glance
- Yes Expedited review granted
- Yes Approval order on file
- Yes 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: