PMA supplement
P850072 S002: DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS
FDA PMA supplement · Panel Track · Ciba Vision Corporation
Key facts
| Original PMA | P850072 |
|---|---|
| Supplement number | S002 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Ciba Vision Corporation |
| Product code | LPM |
| Received date | Nov 12, 1987 |
| Decision date | Feb 24, 1988 |
| Docket number | 88M-0082 |
| Notice date | Mar 30, 1988 |
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: