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 ophthalmic innovations international, inc. To private-label its pma-approved posterior-chamber intraocular lenses for distribution in the united states by ciba vision corporation. The devices as modified will be marketed under the trade-names, ciba vision intraocular lens models 0420f, 0455f, 0440u, 0840u, 0430m, 0840z2, and 0840z, and are indicated for the visual correction of aphakia in persons 60 years of age or older, who are undergoing extracapsular extraction and primary lens implantation.
| Device | POSTERIOR CHAMBER IOL'S |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | AAREN SCIENTIFIC |
| Date Received | 2001-04-19 |
| Decision Date | 2001-06-29 |
| PMA | P970034 |
| Supplement | S009 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Other Report |
| 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 |