PMA
P810042: MODELS 011 & 011B IRIDOCAPSULAR IOLS
FDA PMA · Intraocular lens · Pharmacia, Inc.
Key facts
| PMA number | P810042 |
|---|---|
| Trade name | MODELS 011 & 011B IRIDOCAPSULAR IOLS |
| Generic name | Intraocular lens |
| Applicant | Pharmacia, Inc. |
| Owner/operator | PFIZER INC. |
| Product code | HQL |
| Approval date | Dec 15, 1982 |
| Docket number | 83M-0005 |
| Notice date | Jan 25, 1983 |
| Establishment registration | 1810189 |
| FEI number | 1810189 |
At a glance
- None Supplements
- Dec 15, 1982 Latest supplement decision
- No Withdrawn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: