PMA
P850038: PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN
FDA PMA · Lens, contact (rigid gas permeable), extended wear · Paragon Optical Co.
Key facts
| PMA number | P850038 |
|---|---|
| Trade name | PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN |
| Generic name | Lens, contact (rigid gas permeable), extended wear |
| Applicant | Paragon Optical Co. |
| Product code | MWL |
| Approval date | Dec 31, 1986 |
| Docket number | 87M-0010 |
| Notice date | Feb 18, 1987 |
At a glance
- 10–99 Supplements
- Jan 4, 1994 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- Yes Withdrawn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: