PMA supplement
P960039 S001: SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR)
FDA PMA supplement · 30-Day Notice · Unilens Corporation, USA
Key facts
| Original PMA | P960039 |
|---|---|
| Supplement number | S001 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR) |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Unilens Corporation, USA |
| Product code | LPM |
| Received date | Jun 25, 1998 |
| Decision date | Jul 9, 1998 |
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: