PMA
N17796: BRYREL SYRUP
FDA PMA · Sanofi Aventis U.S., LLC
Key facts
| PMA number | N17796 |
|---|---|
| Trade name | BRYREL SYRUP |
| Applicant | Sanofi Aventis U.S., LLC |
| Approval date | Jun 28, 1976 |
| FEI number | 3002807108 |
At a glance
- None Supplements
- Jun 28, 1976 Latest supplement decision
- Yes Withdrawn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: