PMA
P960036: MEMORYLENS ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL U940A)
FDA PMA · Intraocular lens · Ioltech, S.A.
Key facts
| PMA number | P960036 |
|---|---|
| Trade name | MEMORYLENS ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL U940A) |
| Generic name | Intraocular lens |
| Applicant | Ioltech, S.A. |
| Product code | HQL |
| Approval date | Dec 22, 1997 |
| Docket number | 98M-0137 |
| Notice date | Mar 4, 1998 |
At a glance
- 1–9 Supplements
- Jul 26, 2002 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- Yes Withdrawn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: