PMA supplement
P110005 S003: GELSYN-3
FDA PMA supplement · Special (Immediate Track) · Ibsa Institut Biochimique SA
Key facts
| Original PMA | P110005 |
|---|---|
| Supplement number | S003 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | GELSYN-3 |
| Generic name | Acid, hyaluronic, intraarticular |
| Applicant | Ibsa Institut Biochimique SA |
| Product code | MOZ |
| Received date | Apr 9, 2018 |
| Decision date | May 7, 2018 |
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: