PMA
P820072: CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC
FDA PMA · Intraocular lens · Bausch & Lomb, Inc.
Key facts
| PMA number | P820072 |
|---|---|
| Trade name | CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC |
| Generic name | Intraocular lens |
| Applicant | Bausch & Lomb, Inc. |
| Owner/operator | Bausch & Lomb Incorporated |
| Product code | HQL |
| Approval date | Jul 21, 1983 |
| Notice date | Aug 9, 1983 |
| Establishment registration | 1313525 |
| FEI number | 1317628 |
At a glance
- 10–99 Supplements
- Sep 28, 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- Yes Withdrawn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: