PMA supplement
P830034 S019: OPTI-FREE RINSING,DISINFECTING,& STORAGE SOLUTION
FDA PMA supplement · Normal 180 Day Track · Alcon Laboratories
Key facts
| Original PMA | P830034 |
|---|---|
| Supplement number | S019 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Other |
| Trade name | OPTI-FREE RINSING,DISINFECTING,& STORAGE SOLUTION |
| Generic name | Accessories, soft lens products |
| Applicant | Alcon Laboratories |
| Product code | LPN |
| Received date | Oct 10, 1990 |
| Decision date | Mar 14, 1994 |
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: