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 | OP-3 (TM) RGP CONTACT LENS |
Generic Name | Lens, Contact (other Material) - Daily |
Applicant | STELLAR CONTACT LENS, INC. |
Date Received | 1994-01-27 |
Decision Date | 1994-02-24 |
PMA | P920045 |
Supplement | S001 |
Product Code | HQD |
Advisory Committee | Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Other Report |
Expedited Review | No |
Combination Product | No |
Applicant Address | STELLAR CONTACT LENS, INC. 8131 Tripp Avenue skokie, IL 60076 |
Supplement Number | Date | Supplement Type |
---|---|---|
P920045 | Original Filing | |
S001 | 1994-01-27 | Normal 180 Day Track |