PMA
P800017: CHOYCE MARK VIII ANTERIOR CHAMBER INTEROCULAR LENS
FDA PMA · Intraocular lens · Storz Ophthalmics, Inc.
Key facts
| PMA number | P800017 |
|---|---|
| Trade name | CHOYCE MARK VIII ANTERIOR CHAMBER INTEROCULAR LENS |
| Generic name | Intraocular lens |
| Applicant | Storz Ophthalmics, Inc. |
| Product code | HQL |
| Approval date | Dec 1, 1981 |
| Docket number | 81M-0385 |
| Notice date | Dec 11, 1981 |
At a glance
- 1–9 Supplements
- Jan 27, 1988 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 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: