PMA supplement
P840029 S004: HEMASHIELD ETS(TM) FLANGED GRAFT
FDA PMA supplement · Normal 180 Day Track · Maquet Cardiovascular, LLC
Key facts
| Original PMA | P840029 |
|---|---|
| Supplement number | S004 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | HEMASHIELD ETS(TM) FLANGED GRAFT |
| Generic name | PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER |
| Applicant | Maquet Cardiovascular, LLC |
| Product code | DSY |
| Received date | Oct 24, 1990 |
| Decision date | May 17, 1993 |
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: