PMA
P900053: MODELS A21-A & A21-B POSTERIOR CHAMBER INTRAOCULAR
FDA PMA · Intraocular lens · Vision Technologies Intl., Inc.
Key facts
| PMA number | P900053 |
|---|---|
| Trade name | MODELS A21-A & A21-B POSTERIOR CHAMBER INTRAOCULAR |
| Generic name | Intraocular lens |
| Applicant | Vision Technologies Intl., Inc. |
| Owner/operator | PERFORMANCE VISION TECHNOLOGIES INC. |
| Product code | HQL |
| Approval date | Feb 28, 1991 |
| Docket number | 91M-0089 |
| Notice date | Feb 28, 1991 |
| Establishment registration | 3018565647 |
| FEI number | 3018565647 |
At a glance
- None Supplements
- Feb 28, 1991 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- No Withdrawn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: