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 the memorylens(tm) model u940a ultraviolet-absorbing hydrophilic posterior chamber intraocular lens. This device is indicated for primary implantation for the visual correction of aphakia in patients sixty years of age or older where a cataractous lens has been removed by an extracapsular cataract extraction method. The lens is intended for placement in the capsular bag.
| Device | MEMORYLENS ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL U940A) |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | IOLTECH, S.A. |
| Date Received | 1996-10-01 |
| Decision Date | 1997-12-22 |
| Notice Date | 1998-03-04 |
| PMA | P960036 |
| Supplement | S |
| Product Code | HQL |
| Docket Number | 98M-0137 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | IOLTECH, S.A. 64 Schoosett Street penbroke, MA 02359-1882 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P960036 | Original Filing | |
| S007 | 2002-07-08 | 30-day Notice |
| S006 | 2002-06-06 | Real-time Process |
| S005 | 2001-12-21 | Normal 180 Day Track |
| S004 | 2000-09-18 | Normal 180 Day Track |
| S003 | 2000-08-31 | Normal 180 Day Track |
| S002 | 2000-07-17 | Normal 180 Day Track |
| S001 | 1999-08-23 | Real-time Process |