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 sterilizing the silicone posterior chamber intraocular lens, model 912, at the facility in groningen, the netherland and for changes in the sterilization cycle parameters for model 912 from 100% ethylene oxide (et0) to 20 % et0/80% carbon dioxide.
| Device | CEEON SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES |
| Generic Name | Intraocular Lens |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 2000-09-05 |
| Decision Date | 2001-04-02 |
| PMA | P940007 |
| Supplement | S006 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Express Gmp Supplement |
| 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 |