PMA
P950011: TRUQUANT(R) BR(TM) RIA
FDA PMA · ANTIGEN, CANCER 549 · Biomira, Inc.
Key facts
| PMA number | P950011 |
|---|---|
| Trade name | TRUQUANT(R) BR(TM) RIA |
| Generic name | ANTIGEN, CANCER 549 |
| Applicant | Biomira, Inc. |
| Product code | MJB |
| Approval date | Mar 29, 1996 |
| Docket number | 96M-0216 |
| Notice date | Jul 23, 1996 |
At a glance
- None Supplements
- Mar 29, 1996 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- No Withdrawn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: