PMA supplement
P940015 S012: SYNVISC-ONE
FDA PMA supplement · Panel Track · Sanofi Genzyme Corp.
Key facts
| Original PMA | P940015 |
|---|---|
| Supplement number | S012 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | SYNVISC-ONE |
| Generic name | Acid, hyaluronic, intraarticular |
| Applicant | Sanofi Genzyme Corp. |
| Product code | MOZ |
| Received date | Jun 19, 2007 |
| Decision date | Feb 26, 2009 |
| Docket number | 09M-0128 |
| Notice date | Mar 10, 2009 |
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: