PMA supplement
P830062 S009: ND:YAG POSTERIOR CAPSULOTOMY MODEL 100
FDA PMA supplement · Nidek, Inc.
Key facts
| Original PMA | P830062 |
|---|---|
| Supplement number | S009 |
| 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 |
| Received date | Mar 19, 1986 |
| Decision date | Apr 8, 1987 |
| Docket number | 87M-0139 |
| Notice date | May 18, 1987 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: