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 an alternate formulation using catalase raw material derived from a non-animal source and an associated change in the minimum neutralization soak time from 2 to 4 hours. The alternate formulation includes no changes in the indications for use.
| Device | ULTRA CARE (TM) NEUTRALIZING TABLET |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1996-08-23 |
| Decision Date | 1997-07-03 |
| PMA | P850088 |
| Supplement | S036 |
| Product Code | LPN |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |