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.
Indicated for the visual correction of aphakia in persons 60 years of age or older, who are undergoing extracapsular cataract extraction and primary lens implantation. The intraocular lens is intended to permanently replace the natural cataractous crystalline lens and to restore useful vision. It is intended for capsular bag placement only. The devices are available in a range of powers from 4 diopters (d) to 34d in 0. 5d increments.
| Device | MODIFIED C-LOOP, UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | AAREN SCIENTIFIC |
| Date Received | 1997-07-21 |
| Decision Date | 1998-09-25 |
| Notice Date | 1998-10-27 |
| PMA | P970034 |
| Supplement | S |
| Product Code | HQL |
| Docket Number | 98M-0855 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | AAREN SCIENTIFIC 4290 East Brickell St, Bldg A ontario, CA 91761 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970034 | Original Filing | |
| S014 | 2009-10-28 | 135 Review Track For 30-day Notice |
| S013 | ||
| S012 | 2008-08-13 | 30-day Notice |
| S011 | 2008-08-13 | 30-day Notice |
| S010 | 2007-12-20 | 135 Review Track For 30-day Notice |
| S009 | 2001-04-19 | Normal 180 Day Track |
| S008 | 2001-03-26 | Normal 180 Day Track |
| S007 | 2000-07-06 | Normal 180 Day Track |
| S006 | 2000-04-19 | Normal 180 Day Track |
| S005 | 2000-02-14 | Normal 180 Day Track |
| S004 | 2000-02-14 | Panel Track |
| S003 | 1999-03-23 | 30-day Notice |
| S002 | 1998-12-21 | Normal 180 Day Track |
| S001 | 1998-10-22 | 30-day Notice |