This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | MICRORUPTOR MR-2 ND:YAG LASER SYSTEM |
| Generic Name | Laser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary |
| Applicant | MERIDIAN AG |
| Date Received | 1984-03-19 |
| Decision Date | 1986-01-31 |
| Notice Date | 1986-03-28 |
| PMA | P840012 |
| Supplement | S |
| Product Code | LOI |
| Docket Number | 86M-0106 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MERIDIAN AG bierigutstrauss 7 ch-3608 thun, Be |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P840012 | Original Filing | |
| S007 | 1989-12-20 | Normal 180 Day Track |
| S006 | 1989-12-07 | Normal 180 Day Track |
| S005 | 1988-10-04 | Normal 180 Day Track |
| S004 | ||
| S003 | 1987-04-01 | Panel Track |
| S002 | 1987-03-26 | Normal 180 Day Track |
| S001 | 1986-01-22 |