PMA
P780010: PERMALENS (PERFILCON A) SOFT HYDROPHILIC CONTACT LENS
FDA PMA · Lenses, soft contact, extended wear · CooperVision, Inc.
Key facts
| PMA number | P780010 |
|---|---|
| Trade name | PERMALENS (PERFILCON A) SOFT HYDROPHILIC CONTACT LENS |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | CooperVision, Inc. |
| Owner/operator | COOPERVISION, INC. |
| Product code | LPM |
| Approval date | Jun 11, 1979 |
| Notice date | Dec 28, 1979 |
| Establishment registration | 1314956 |
| FEI number | 1314956 |
At a glance
- 10–99 Supplements
- Nov 16, 2001 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- Yes Withdrawn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: