PMA
P820049: MODELS PC10 & PC21
FDA PMA · Intraocular lens · Advanced Medical Optics, Inc.
Key facts
| PMA number | P820049 |
|---|---|
| Trade name | MODELS PC10 & PC21 |
| Generic name | Intraocular lens |
| Applicant | Advanced Medical Optics, Inc. |
| Owner/operator | OPTICS INCORPORATED |
| Product code | HQL |
| Approval date | May 17, 1983 |
| Docket number | 83M-0174 |
| Notice date | Jun 17, 1983 |
| Establishment registration | 3017541416 |
| FEI number | 3017541416 |
At a glance
- 10–99 Supplements
- Oct 7, 1997 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- Yes Withdrawn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: