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.
| Device | TIER A MODELS 24050,24150,25050,25350-125 LENSES |
| Generic Name | Intraocular Lens |
| Applicant | EYETECH, LLC. |
| Date Received | 1991-05-01 |
| Decision Date | 1991-09-04 |
| PMA | P880082 |
| Supplement | S012 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | EYETECH, LLC. 7016 6th St. North oakdale, MN 55128 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P880082 | Original Filing | |
| S018 | 1995-06-14 | Normal 180 Day Track |
| S017 | 1994-02-03 | Normal 180 Day Track |
| S016 | ||
| S015 | ||
| S014 | 1992-03-05 | Normal 180 Day Track |
| S013 | 1991-05-24 | Normal 180 Day Track |
| S012 | 1991-05-01 | Normal 180 Day Track |
| S011 | 1991-01-09 | Normal 180 Day Track |
| S010 | ||
| S009 | 1990-11-21 | Normal 180 Day Track |
| S008 | 1990-04-26 | Normal 180 Day Track |
| S007 | 1990-04-26 | Normal 180 Day Track |
| S006 | ||
| S005 | 1990-04-26 | Normal 180 Day Track |
| S004 | ||
| S003 | 1989-11-24 | Normal 180 Day Track |
| S002 | 1989-05-30 | Normal 180 Day Track |
| S001 |