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 | ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING |
| Generic Name | Intraocular Lens |
| Applicant | CILCO, INC. |
| Date Received | 1991-08-21 |
| Decision Date | 1991-12-20 |
| PMA | P820016 |
| Supplement | S002 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CILCO, INC. 1616 13th Avenue Huntington, west Virginia |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P820016 | Original Filing | |
| S002 | 1991-08-21 | Normal 180 Day Track |
| S001 |