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 | MICRO YAG ND:YAG LASER SYSTEM |
| Generic Name | Laser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary |
| Applicant | SORIN GROUP USA INC. |
| Date Received | 1986-05-19 |
| Decision Date | 1986-06-17 |
| PMA | P850063 |
| Supplement | S001 |
| Product Code | LOI |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SORIN GROUP USA INC. 14401 West 65th Way arvada, CO 80004 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850063 | Original Filing | |
| S001 | 1986-05-19 |