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 steri-tech, inc. , p. O. Box 1145, salinas, puerto rico 00751 as an alternate contract sterilization site, and for the use of 100% ethylene oxide to sterilize plastic bottles, tips, and caps used in the manufacture of the devices
| Device | ULTRA CARE (TM) NEUTRALIZING TABLET |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1995-06-08 |
| Decision Date | 1996-02-23 |
| PMA | P850088 |
| Supplement | S034 |
| Product Code | LPN |
| 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. 2525 Dupont Dr. irvine, CA 92612 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850088 | Original Filing | |
| S036 | 1996-08-23 | Normal 180 Day Track |
| S035 | ||
| S034 | 1995-06-08 | Normal 180 Day Track |
| S033 | 1995-05-05 | Normal 180 Day Track |
| S032 | 1995-03-03 | Normal 180 Day Track |
| S031 | 1994-01-21 | Normal 180 Day Track |
| S030 | 1992-11-18 | Normal 180 Day Track |
| S029 | 1992-10-28 | Normal 180 Day Track |
| S028 | 1992-05-28 | Normal 180 Day Track |
| S027 | 1992-05-13 | Normal 180 Day Track |
| S026 | 1992-03-11 | Normal 180 Day Track |
| S025 | 1992-03-10 | Normal 180 Day Track |
| S024 | 1991-11-13 | Normal 180 Day Track |
| S023 | ||
| S022 | 1991-02-14 | Normal 180 Day Track |
| S021 | 1990-11-23 | Normal 180 Day Track |
| S020 | 1990-10-11 | Normal 180 Day Track |
| S019 | 1990-08-16 | Normal 180 Day Track |
| S018 | 1990-05-31 | Normal 180 Day Track |
| S017 | ||
| S016 | 1990-05-21 | Normal 180 Day Track |
| S015 | ||
| S014 | 1989-12-20 | Normal 180 Day Track |
| S013 | 1989-12-11 | Normal 180 Day Track |
| S012 | 1989-11-29 | Normal 180 Day Track |
| S011 | 1989-11-27 | Normal 180 Day Track |
| S010 | 1989-11-21 | Normal 180 Day Track |
| S009 | 1989-11-01 | Normal 180 Day Track |
| S008 | 1989-10-23 | Normal 180 Day Track |
| S007 | 1989-09-29 | Normal 180 Day Track |
| S006 | ||
| S005 | 1989-01-25 | Normal 180 Day Track |
| S004 | 1988-09-30 | Normal 180 Day Track |
| S003 | 1988-04-14 | Normal 180 Day Track |
| S002 | 1987-10-13 | Normal 180 Day Track |
| S001 | 1987-03-16 | 30-Day Supplement |