PMA
P950027: HYALGAN(R)
FDA PMA · Acid, hyaluronic, intraarticular · Fidia Farmaceutici S.P.A.
Key facts
| PMA number | P950027 |
|---|---|
| Trade name | HYALGAN(R) |
| Generic name | Acid, hyaluronic, intraarticular |
| Applicant | Fidia Farmaceutici S.P.A. |
| Owner/operator | Fidia Farmaceutici SPA |
| Product code | MOZ |
| Approval date | May 28, 1997 |
| Docket number | 98M-0980 |
| Notice date | Dec 7, 1998 |
| Establishment registration | 9610200 |
| FEI number | 3002806986 |
At a glance
- 10–99 Supplements
- Jun 28, 2024 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- No Withdrawn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: