PMA
P900037: MODIFIED J&C LOOP POST. CHAMBER INTRAOCULAR LENS
FDA PMA · Intraocular lens · Medical Development Research, Inc.
Key facts
| PMA number | P900037 |
|---|---|
| Trade name | MODIFIED J&C LOOP POST. CHAMBER INTRAOCULAR LENS |
| Generic name | Intraocular lens |
| Applicant | Medical Development Research, Inc. |
| Owner/operator | INTERNATIONAL MEDICAL DEVELOPMENT, INC. |
| Product code | HQL |
| Approval date | Feb 28, 1991 |
| Docket number | 91M-0088 |
| Notice date | Apr 2, 1991 |
| Establishment registration | 1722686 |
| FEI number | 1000220636 |
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- No Withdrawn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: