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 | N-18 (KOLFOCON A),N-32 (KOLFOCON B) LENS MATERIAL |
Generic Name | Lens, Contact (other Material) - Daily |
Applicant | THE LAGADO CORP. |
Date Received | 1993-03-05 |
Decision Date | 1994-02-24 |
PMA | P880024 |
Supplement | S002 |
Product Code | HQD |
Advisory Committee | Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Other Report |
Expedited Review | No |
Combination Product | No |
Applicant Address | THE LAGADO CORP. 2890 South Tejon St. englewood, CO 80110 |
Supplement Number | Date | Supplement Type |
---|---|---|
P880024 | Original Filing | |
S003 | 1993-03-05 | Normal 180 Day Track |
S002 | 1993-03-05 | Normal 180 Day Track |
S001 |
Device ID | PMA | Supp |
---|---|---|
00858174006027 | P880024 | 002 |
00858174006010 | P880024 | 002 |