PMA supplement
P840012 S003: MICRORUPTOR MR-2 ND:YAG LASER SYSTEM
FDA PMA supplement · Panel Track · Meridian AG
Key facts
| Original PMA | P840012 |
|---|---|
| Supplement number | S003 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | MICRORUPTOR MR-2 ND:YAG LASER SYSTEM |
| Generic name | Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary |
| Applicant | Meridian AG |
| Product code | LOI |
| Received date | Apr 1, 1987 |
| Decision date | Aug 27, 1987 |
| Docket number | 87M-0305 |
| Notice date | Oct 19, 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: