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 |