PMA supplement
P830025 S001: MEDITEC OPL3 ND:YAG LASER
FDA PMA supplement · Medical Laser, Inc.
Key facts
| Original PMA | P830025 |
|---|---|
| Supplement number | S001 |
| Trade name | MEDITEC OPL3 ND:YAG LASER |
| Generic name | Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary |
| Applicant | Medical Laser, Inc. |
| Product code | LOI |
| Received date | Feb 22, 1985 |
| Decision date | Jun 25, 1985 |
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: