PMA supplement
P870009 S001: 3M FLUOROPOLYMER CONTACT LENS (FLUROFOCON A)
FDA PMA supplement · Panel Track · 3M Company
Key facts
| Original PMA | P870009 |
|---|---|
| Supplement number | S001 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | 3M FLUOROPOLYMER CONTACT LENS (FLUROFOCON A) |
| Generic name | Lens, contact (polymethylmethacrylate) |
| Applicant | 3M Company |
| Product code | HPX |
| Received date | Sep 23, 1987 |
| Decision date | Jun 21, 1988 |
| Docket number | 88M-0255 |
| Notice date | Aug 4, 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: