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 | THE BOSTON LENS II ALGES(R) BIFOCAL CONTACT LENS |
| Generic Name | Lens, Contact (polymethylmethacrylate) |
| Applicant | Unilens Corp., USA |
| Date Received | 1986-08-14 |
| Decision Date | 1986-12-01 |
| PMA | P850008 |
| Supplement | S001 |
| Product Code | HPX |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Unilens Corp., USA 10431 72nd St. North p.o. Box 2530 largo, FL 34647 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850008 | Original Filing | |
| S001 | 1986-08-14 | Normal 180 Day Track |