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 modify the "indications" statements for all legally marketed iols under the above referenced pmas to reflect adults as opposed to adults older than 60 years of age.
| Device | CEEON HEPARIN SURFACE MODIFIED UV-LIGHT ABSORBING ANTERIOR CHAMBER (IOLS) |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | ABBOTT MEDICAL OPTICS INC |
| Date Received | 2005-01-03 |
| Decision Date | 2005-02-04 |
| PMA | P880070 |
| Supplement | S011 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |