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.
Addition of a second eto sterilizer (gee 6913 ar-1) used in the sterilization of iols manufactured at the amo groningen, netherlands facility.
| Device | CEEON HEPARIN SURFACE MODIFIED (HSM) UV LIGHT-ABSORBING POSTERIOR CHAMBER IOLS |
| Generic Name | Intraocular Lens |
| Applicant | ABBOTT MEDICAL OPTICS INC |
| Date Received | 2007-04-12 |
| Decision Date | 2007-05-08 |
| PMA | P960034 |
| Supplement | S002 |
| Product Code | HQL |
| Advisory Committee | Neurology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |
|---|---|---|
| P960034 | Original Filing | |
| S002 | 2007-04-12 | 30-day Notice |
| S001 | 1999-12-20 | Real-time Process |