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 the use of an alternate sterilizer at the manufacturing site in groningen, the netherlands.
| Device | MODEL UV65 SERIES ANTERIOR CHAMBER LENSES |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | ABBOTT MEDICAL OPTICS INC |
| Date Received | 1996-05-23 |
| Decision Date | 1998-02-02 |
| PMA | P880070 |
| Supplement | S007 |
| 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 | 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 |