PMA
P840029: MICROVEL(R) WITH HEMASHIELD
FDA PMA · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER · Maquet Cardiovascular, LLC
Key facts
| PMA number | P840029 |
|---|---|
| Trade name | MICROVEL(R) WITH HEMASHIELD |
| Generic name | PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER |
| Applicant | Maquet Cardiovascular, LLC |
| Owner/operator | Maquet Cardiovascular LLC |
| Product code | DSY |
| Approval date | Apr 26, 1989 |
| Docket number | 89M-0170 |
| Notice date | Jun 6, 1989 |
| Establishment registration | 2242352 |
| FEI number | 2242352 |
At a glance
- 10–99 Supplements
- May 17, 1993 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: