This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for model ws-100 pliolens ultraviolet-absorbing silicone posterior chamber intraocular lens
| Device | PLIOLENS UV ABSORBING SILICONE POST. CHAM. IOL |
| Generic Name | Intraocular Lens |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1994-02-28 |
| Decision Date | 1995-07-20 |
| Notice Date | 1995-12-19 |
| PMA | P940007 |
| Supplement | S |
| Product Code | HQL |
| Docket Number | 95m-0395 |
| Advisory Committee | Ophthalmic |
| 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 |