PMA
P870024: FLUOROPERM RGP CONTACT LENSES
FDA PMA · Lens, contact (rigid gas permeable), extended wear · CooperVision, Inc.
Key facts
| PMA number | P870024 |
|---|---|
| Trade name | FLUOROPERM RGP CONTACT LENSES |
| Generic name | Lens, contact (rigid gas permeable), extended wear |
| Applicant | CooperVision, Inc. |
| Owner/operator | COOPERVISION, INC. |
| Product code | MWL |
| Approval date | Dec 31, 1987 |
| Docket number | 88M-0013 |
| Notice date | Feb 22, 1988 |
| Establishment registration | 1314956 |
| FEI number | 1314956 |
At a glance
- 10–99 Supplements
- Jun 16, 2022 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 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: