PMA supplement
P140016 S004: ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT
FDA PMA supplement · Special (Immediate Track) · Cook Medical Incorporated
Key facts
| Original PMA | P140016 |
|---|---|
| Supplement number | S004 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT |
| Generic name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Applicant | Cook Medical Incorporated |
| Product code | MIH |
| Received date | Dec 3, 2021 |
| Decision date | Dec 22, 2021 |
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: