PMA supplement
P820065 S038: BOSTON LENS(R) LENS - CLEAR
FDA PMA supplement · THIRTY DAY TRACK · Polymer Technology Corp.
Key facts
| Original PMA | P820065 |
|---|---|
| Supplement number | S038 |
| Supplement type | THIRTY DAY TRACK |
| Reason for the supplement | Other |
| Trade name | BOSTON LENS(R) LENS - CLEAR |
| Generic name | Lens, contact (polymethylmethacrylate) |
| Applicant | Polymer Technology Corp. |
| Product code | HPX |
| Received date | Oct 28, 1986 |
| Decision date | Nov 18, 1986 |
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: