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 single-pouch tyvek packaging of lenses produced in irvine, ca & anasco, pr, sterilization of lenses using previously approved 100% (eto) sterilization cycles & a 5 year shelf life for single-pouch/100% eto sterilized lenses
| Device | MODELS AC-21/AC-21B ANTERIOR CHAMBER IOL |
| Generic Name | Intraocular Lens |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1995-04-04 |
| Decision Date | 1995-07-28 |
| PMA | P860034 |
| Supplement | S012 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ADVANCED MEDICAL OPTICS, INC. 1700 E. St. Andrew Place p.o. Box 25162 santa Ana, CA 92705-4933 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P860034 | Original Filing | |
| S015 | 1997-06-30 | Real-time Process |
| S014 | 1995-11-13 | Normal 180 Day Track |
| S013 | 1995-11-03 | Normal 180 Day Track |
| S012 | 1995-04-04 | Normal 180 Day Track |
| S011 | 1994-01-13 | Normal 180 Day Track |
| S010 | 1992-07-21 | Normal 180 Day Track |
| S009 | 1992-06-30 | Normal 180 Day Track |
| S008 | 1991-01-25 | Normal 180 Day Track |
| S007 | 1990-02-28 | Normal 180 Day Track |
| S006 | ||
| S005 | ||
| S004 | ||
| S003 | ||
| S002 | ||
| S001 |