PMA supplement
P890040 S004: SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC LENS
FDA PMA supplement · Normal 180 Day Track · Unilens Corp., USA
Key facts
| Original PMA | P890040 |
|---|---|
| Supplement number | S004 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC LENS |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Unilens Corp., USA |
| Product code | LPM |
| Received date | Nov 25, 1991 |
| Decision date | Jun 29, 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: