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 isotron ireland, ltd. Located at sragh industrial estate, tullamore, co. Offaly, ireland, as an alternate contract sterilization site, and for the use of 100% ethylene oxide to sterilize the plastic bottles, tips, and caps
| Device | OXYSEPT 1 & ULTRACARE DISINFECTING SOLUTIONS & OXYSEPT 2 NEUTRALIZING SOLUTION |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1995-05-05 |
| Decision Date | 1996-04-12 |
| PMA | P850088 |
| Supplement | S033 |
| 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 |