PMA supplement
P880091 S014: UV-ABSORBING SILICONE POSTERIOR CHAMBER IOLS W/TORIC OPTIC
FDA PMA supplement · Panel Track · Staar Surgical Co.
Key facts
| Original PMA | P880091 |
|---|---|
| Supplement number | S014 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | UV-ABSORBING SILICONE POSTERIOR CHAMBER IOLS W/TORIC OPTIC |
| Generic name | LENS, INTRAOCULAR, TORIC OPTICS |
| Applicant | Staar Surgical Co. |
| Product code | MJP |
| Received date | Dec 16, 1997 |
| Decision date | Nov 4, 1998 |
| Docket number | 98M-0998 |
| Notice date | Dec 17, 1998 |
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: