PMA
P920027: ALBUMIN COATED DEBAKEY(R) VASCULAR(R) VASCULAR-II
FDA PMA · GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE · C.R. Bard, Inc.
Key facts
| PMA number | P920027 |
|---|---|
| Trade name | ALBUMIN COATED DEBAKEY(R) VASCULAR(R) VASCULAR-II |
| Generic name | GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE |
| Applicant | C.R. Bard, Inc. |
| Owner/operator | C. R. Bard, Inc. |
| Product code | MAL |
| Approval date | Oct 21, 1994 |
| Docket number | 97M-0203 |
| Notice date | May 27, 1997 |
| Establishment registration | 1018233 |
| FEI number | 1018233 |
At a glance
- None Supplements
- Oct 21, 1994 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- None 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: