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 a manufacturing site located at pharmacia & upjohn groningen bv, van swietenlaan 5, nl-9728, nx groningen, the netherlands.
| Device | SILICONE POSTERIOR CHAMBER INTRACULAR LENSES IOL MODEL 127(920) |
| Generic Name | Intraocular Lens |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1998-07-31 |
| Decision Date | 1998-09-29 |
| PMA | P940007 |
| Supplement | S004 |
| 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 | ADVANCED MEDICAL OPTICS, INC. 1700 E. St. Andrew Place p.o. Box 25162 santa Ana, CA 92705-4933 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P940007 | Original Filing | |
| S006 | 2000-09-05 | Normal 180 Day Track |
| S005 | 1999-07-01 | Special (immediate Track) |
| S004 | 1998-07-31 | Normal 180 Day Track |
| S003 | ||
| S002 | 1996-10-17 | Normal 180 Day Track |
| S001 | 1995-10-30 | Normal 180 Day Track |