PMA
P830062: ND:YAG POSTERIOR CAPSULOTOMY MODEL 100
FDA PMA · Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary · Nidek, Inc.
Key facts
| PMA number | P830062 |
|---|---|
| Trade name | ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 |
| Generic name | Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary |
| Applicant | Nidek, Inc. |
| Product code | LOI |
| Approval date | Sep 27, 1984 |
| Docket number | 84M-0353 |
| Notice date | Nov 26, 1984 |
| FEI number | 3002807715 |
At a glance
- 10–99 Supplements
- Mar 13, 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- Yes Withdrawn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: