PMA
P830047: X-70 SOFT CONTACT LENS
FDA PMA · Lenses, soft contact, extended wear · Advanced Medical Optics, Inc.
Key facts
| PMA number | P830047 |
|---|---|
| Trade name | X-70 SOFT CONTACT LENS |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Advanced Medical Optics, Inc. |
| Owner/operator | OPTICS INCORPORATED |
| Product code | LPM |
| Approval date | Mar 29, 1985 |
| Docket number | 85M-0166 |
| Notice date | May 10, 1985 |
| Establishment registration | 3017541416 |
| FEI number | 3017541416 |
At a glance
- 1–9 Supplements
- Jul 26, 1991 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- Yes Withdrawn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: