This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| 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 | 1987-04-01 |
| Decision Date | 1987-08-27 |
| Notice Date | 1987-10-19 |
| PMA | P840012 |
| Supplement | S003 |
| Product Code | LOI |
| Docket Number | 87M-0305 |
| Advisory Committee | Ophthalmic |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |