PMA
P820044: MODEL 91-50 IOL
FDA PMA · Intraocular lens · Bausch & Lomb, Inc.
Key facts
| PMA number | P820044 |
|---|---|
| Trade name | MODEL 91-50 IOL |
| Generic name | Intraocular lens |
| Applicant | Bausch & Lomb, Inc. |
| Owner/operator | Bausch & Lomb Incorporated |
| Product code | HQL |
| Approval date | Dec 27, 1985 |
| Docket number | 86M-0032 |
| Notice date | Feb 14, 1986 |
| Establishment registration | 1313525 |
| FEI number | 1317628 |
At a glance
- 1–9 Supplements
- Mar 19, 1990 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- Yes Withdrawn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: