PMA supplement
P170007 S003: Durolane, Hyaluronic Acid, Stabilized Single Injection
FDA PMA supplement · 30-Day Notice · Bioventus, LLC
Key facts
| Original PMA | P170007 |
|---|---|
| Supplement number | S003 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Durolane, Hyaluronic Acid, Stabilized Single Injection |
| Generic name | Acid, hyaluronic, intraarticular |
| Applicant | Bioventus, LLC |
| Product code | MOZ |
| Received date | May 9, 2019 |
| Decision date | Jun 8, 2019 |
At a glance
- No Expedited review granted
- No Approval order on file
- No 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: