PMA supplement
P850038 S018: PARAPERM E.W. (PASIFOCON C) RGP GRAY TINT
FDA PMA supplement · Normal 180 Day Track · Paragon Optical Co.
Key facts
| Original PMA | P850038 |
|---|---|
| Supplement number | S018 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | PARAPERM E.W. (PASIFOCON C) RGP GRAY TINT |
| Generic name | Lens, contact (other material) - daily |
| Applicant | Paragon Optical Co. |
| Product code | HQD |
| Received date | Feb 11, 1992 |
| Decision date | Jun 12, 1992 |
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: