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 |