PMA supplement
P820005 S006: (POLYMACON) SOF-FORM II CONTACT LENSES
FDA PMA supplement · Normal 180 Day Track · Salvatori Ophthalmics Mfg. Corp.
Key facts
| Original PMA | P820005 |
|---|---|
| Supplement number | S006 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | (POLYMACON) SOF-FORM II CONTACT LENSES |
| Generic name | Lenses, soft contact, daily wear |
| Applicant | Salvatori Ophthalmics Mfg. Corp. |
| Product code | LPL |
| Received date | Dec 29, 1989 |
| Decision date | Jan 31, 1990 |
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: