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.
Approval to modify the current maximum level of ethylene oxide residual from "not to exceed 25 ppm" to "not to exceed 1. 0 ug/lens. "
| Device | MODEL PC-28LB POSTERIOR CHAMBER INTRAOCULAR LENS |
| Generic Name | Intraocular Lens |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1995-11-03 |
| Decision Date | 1997-10-07 |
| PMA | P890056 |
| Supplement | S003 |
| Product Code | HQL |
| Docket Number | N |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ADVANCED MEDICAL OPTICS, INC. 1700 East St. Andrew Pl. santa Ana, CA 92705 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P890056 | Original Filing | |
| S005 | 1997-06-30 | Real-time Process |
| S004 | 1995-11-13 | Normal 180 Day Track |
| S003 | 1995-11-03 | Normal 180 Day Track |
| S002 | 1995-04-04 | Normal 180 Day Track |
| S001 | 1991-01-25 | Normal 180 Day Track |