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.
Reduction of the incubation time for biological indicators used in sterility testing
| Device | IOPTEX PMMA ANTERIOR CHAMBER IOLS |
| Generic Name | Intraocular Lens |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1996-06-18 |
| Decision Date | 1996-10-07 |
| PMA | P880085 |
| Supplement | S003 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ADVANCED MEDICAL OPTICS, INC. 1700 E. St. Andrew Place p.o. Box 25162 santa Ana, CA 92705-4933 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P880085 | Original Filing | |
| S003 | 1996-06-18 | Normal 180 Day Track |
| S002 | ||
| S001 |