PMA
P110005: SINOVIAL (SODIUM HYALURONATE 0.8%)
FDA PMA · Acid, hyaluronic, intraarticular · Ibsa Institut Biochimique SA
Key facts
| PMA number | P110005 |
|---|---|
| Trade name | SINOVIAL (SODIUM HYALURONATE 0.8%) |
| Generic name | Acid, hyaluronic, intraarticular |
| Applicant | Ibsa Institut Biochimique SA |
| Owner/operator | IBSA Institut Biochimique SA |
| Product code | MOZ |
| Approval date | May 9, 2014 |
| Docket number | 14M-0691 |
| Notice date | May 29, 2014 |
| Establishment registration | 3002864272 |
| FEI number | 3002864272 |
At a glance
- 10–99 Supplements
- Jul 24, 2026 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- No Withdrawn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: