PMA supplement
P070016 S005: ZENITH TX2 TAA ENDOVASCULAR GRAFT
FDA PMA supplement · 135 Review Track For 30-Day Notice · William Cook Europe Aps
Key facts
| Original PMA | P070016 |
|---|---|
| Supplement number | S005 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | ZENITH TX2 TAA ENDOVASCULAR GRAFT |
| Generic name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Applicant | William Cook Europe Aps |
| Product code | MIH |
| Received date | Jul 12, 2011 |
| Decision date | Nov 5, 2012 |
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: