PMA supplement
P150010 S005: HYMOVIS ONE
FDA PMA supplement · Panel Track · Fidia Farmaceutici
Key facts
| Original PMA | P150010 |
|---|---|
| Supplement number | S005 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | HYMOVIS ONE |
| Generic name | Acid, hyaluronic, intraarticular |
| Applicant | Fidia Farmaceutici |
| Product code | MOZ |
| Received date | Dec 23, 2024 |
| Decision date | Apr 9, 2025 |
| Docket number | 25M-1101 |
| Notice date | Apr 21, 2025 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: