PMA supplement
P080020 S020: GEL-ONE(R)
FDA PMA supplement · Panel Track · Seikagaku Corp.
Key facts
| Original PMA | P080020 |
|---|---|
| Supplement number | S020 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | GEL-ONE(R) |
| Generic name | Acid, hyaluronic, intraarticular |
| Applicant | Seikagaku Corp. |
| Product code | MOZ |
| Received date | Apr 1, 2016 |
| Decision date | Sep 27, 2016 |
| Docket number | 16M-2975 |
| Notice date | Sep 30, 2016 |
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: