PMA supplement
P800028 S004: THE BLAIREX SYSTEM
FDA PMA supplement · Blairex Laboratories, Inc.
Key facts
| Original PMA | P800028 |
|---|---|
| Supplement number | S004 |
| Trade name | THE BLAIREX SYSTEM |
| Generic name | Accessories, soft lens products |
| Applicant | Blairex Laboratories, Inc. |
| Product code | LPN |
| Received date | Apr 22, 1982 |
| Decision date | May 11, 1982 |
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: