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 for alternate sterilization parameters for the 100% ethylene oxide (eto) sterilization process for iols sterilized at steri-tech, inc. , salinas, puerto rico.
| Device | MODEL PC-28LB POSTERIOR CHAMBER INTRAOCULAR LENS |
| Generic Name | Intraocular Lens |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1997-06-30 |
| Decision Date | 1997-10-02 |
| PMA | P890056 |
| Supplement | S005 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| 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 |