PMA supplement
P000046 S016: OPTIVISC
FDA PMA supplement · Normal 180 Day Track No User Fee · Anika Therapeutics, Inc.
Key facts
| Original PMA | P000046 |
|---|---|
| Supplement number | S016 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | OPTIVISC |
| Generic name | AID, SURGICAL, VISCOELASTIC |
| Applicant | Anika Therapeutics, Inc. |
| Product code | LZP |
| Received date | Oct 2, 2009 |
| Decision date | Feb 12, 2010 |
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: