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 | ELASTIMIDE(TM) IOL MODEL AQ-2010 |
| Generic Name | Intraocular Lens |
| Applicant | STAAR SURGICAL CO. |
| Date Received | 1992-04-30 |
| Decision Date | 1994-04-20 |
| PMA | P910060 |
| Supplement | S001 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | STAAR SURGICAL CO. 1911 Walker Ave. monrovia, CA 91016 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P910060 | Original Filing | |
| S001 | 1992-04-30 | Normal 180 Day Track |