PMA supplement
P850077 S004: SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS
FDA PMA supplement · THIRTY DAY TRACK · CooperVision, Inc.
Key facts
| Original PMA | P850077 |
|---|---|
| Supplement number | S004 |
| Supplement type | THIRTY DAY TRACK |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS |
| Generic name | Lenses, soft contact, daily wear |
| Applicant | CooperVision, Inc. |
| Product code | LPL |
| Received date | Dec 11, 1986 |
| Decision date | Feb 17, 1987 |
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: