PMA
P880098: MENICON SF-P RGP (MELAFOCON A) CONTACT LENS
FDA PMA · Lens, contact (rigid gas permeable), extended wear · Menicon Co, Ltd.
Key facts
| PMA number | P880098 |
|---|---|
| Trade name | MENICON SF-P RGP (MELAFOCON A) CONTACT LENS |
| Generic name | Lens, contact (rigid gas permeable), extended wear |
| Applicant | Menicon Co, Ltd. |
| Owner/operator | MENICON CO. LTD. |
| Product code | MWL |
| Approval date | Sep 1, 1989 |
| Docket number | 89M-0388 |
| Notice date | Oct 19, 1989 |
| Establishment registration | 9614761 |
| FEI number | 1000188353 |
At a glance
- 10–99 Supplements
- Dec 10, 2002 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: