PMA supplement
P960011 S029: BVI 1% OVD (formerly BD 1% OVD and Biolon)
FDA PMA supplement · Special (Immediate Track) · Altacor, Ltd.
Key facts
| Original PMA | P960011 |
|---|---|
| Supplement number | S029 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | BVI 1% OVD (formerly BD 1% OVD and Biolon) |
| Generic name | AID, SURGICAL, VISCOELASTIC |
| Applicant | Altacor , Ltd. |
| Product code | LZP |
| Received date | Feb 12, 2018 |
| Decision date | Mar 15, 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: