PMA
P150010: HYMOVIS
FDA PMA · Acid, hyaluronic, intraarticular · Fidia Farmaceutici
Key facts
| PMA number | P150010 |
|---|---|
| Trade name | HYMOVIS |
| Generic name | Acid, hyaluronic, intraarticular |
| Applicant | Fidia Farmaceutici |
| Owner/operator | Fidia Farmaceutici SPA |
| Product code | MOZ |
| Approval date | Aug 28, 2015 |
| Docket number | 15M-3256 |
| Notice date | Oct 14, 2015 |
| Establishment registration | 9610200 |
| FEI number | 3002806986 |
At a glance
- 1–9 Supplements
- Apr 9, 2025 Latest supplement decision
- No Withdrawn
- Yes 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: