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 to change the material and the manufacturing process, to add a heparin surface modification, and to change the lens model designation form uv65b to hsm65.
| Device | MODEL HSM65 UV ABSORBING PMMA ANTERIOR CHAMBER LENS |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | ABBOTT MEDICAL OPTICS INC |
| Date Received | 2003-11-07 |
| Decision Date | 2004-03-17 |
| PMA | P880070 |
| Supplement | S010 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT MEDICAL OPTICS INC 1700 E. St. Andrew Place santa Ana, CA 92705 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P880070 | Original Filing | |
| S012 | 2007-04-12 | 30-day Notice |
| S011 | 2005-01-03 | Real-time Process |
| S010 | 2003-11-07 | Real-time Process |
| S009 | ||
| S008 | 1998-06-23 | Real-time Process |
| S007 | 1996-05-23 | Normal 180 Day Track |
| S006 | ||
| S005 | 1992-11-05 | Normal 180 Day Track |
| S004 | 1992-06-16 | Normal 180 Day Track |
| S003 | 1991-08-09 | Normal 180 Day Track |
| S002 | 1990-03-12 | Normal 180 Day Track |
| S001 | 1989-08-29 | Normal 180 Day Track |