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 add sterilization services of tennesse (sst) as an alternate 100% eto sterilization site for iols produced in irvine, ca and anasco, pr and packaged in the single-pouch tyvek packagin configuratio currently approved under these pmas for sterilization at sterilization services of georgia (ssg)
| Device | MODELS AC-21/AC-21B ANTERIOR CHAMBER IOL |
| Generic Name | Intraocular Lens |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1995-11-13 |
| Decision Date | 1996-03-11 |
| PMA | P860034 |
| Supplement | S014 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location 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 |