PMA
P870045: SK15 AND SK16
FDA PMA · Intraocular lens · Bausch & Lomb, Inc.
Key facts
| PMA number | P870045 |
|---|---|
| Trade name | SK15 AND SK16 |
| Generic name | Intraocular lens |
| Applicant | Bausch & Lomb, Inc. |
| Owner/operator | Bausch & Lomb Incorporated |
| Product code | HQL |
| Approval date | Jan 24, 1990 |
| Docket number | 90M-0053 |
| Notice date | Feb 27, 1990 |
| Establishment registration | 1313525 |
| FEI number | 1317628 |
At a glance
- 10–99 Supplements
- Dec 28, 1998 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- Yes Withdrawn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: