PMA
P850059: KELMAN(TM) OMNIFIT II MODEL 2100
FDA PMA · Intraocular lens · Bausch & Lomb Surgical, Inc.
Key facts
| PMA number | P850059 |
|---|---|
| Trade name | KELMAN(TM) OMNIFIT II MODEL 2100 |
| Generic name | Intraocular lens |
| Applicant | Bausch & Lomb Surgical, Inc. |
| Owner/operator | Bausch & Lomb Incorporated |
| Product code | HQL |
| Approval date | Jul 31, 1986 |
| Docket number | 87M-0008 |
| Notice date | Feb 18, 1987 |
| Establishment registration | 1313525 |
| FEI number | 1317628 |
At a glance
- 10–99 Supplements
- Aug 13, 2003 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- Yes Withdrawn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: