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 sterilization site, and for the use of 100% ethylene oxide to sterilize plastic bottles, tips, and caps
| Device | ALLERGAN(R) HYDROCARE(R) CLEAN & DISINFECT SOLUTIO |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1995-06-08 |
| Decision Date | 1996-02-23 |
| PMA | N17786 |
| Supplement | S025 |
| 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 |
|---|---|---|
| N17786 | Original Filing | |
| S025 | 1995-06-08 | Normal 180 Day Track |
| S024 | 1995-05-05 | Normal 180 Day Track |
| S023 | ||
| S022 | 1989-09-29 | Normal 180 Day Track |
| S021 | 1989-06-15 | Normal 180 Day Track |
| S020 | ||
| S019 | ||
| S018 | ||
| S017 | 1988-04-14 | Normal 180 Day Track |
| S016 | 1988-01-25 | Normal 180 Day Track |
| S015 | 1987-03-16 | 30-Day Supplement |
| S014 | 1984-06-04 | |
| S013 | 1984-04-23 | |
| S012 | ||
| S011 | 1982-09-29 | |
| S010 | 1982-06-07 | |
| S009 | 1982-05-06 | |
| S008 | 1982-04-12 | |
| S007 | 1982-03-29 | |
| S006 | 1982-03-04 | |
| S005 | 1981-07-28 | |
| S004 | 1981-05-19 | |
| S003 | 1981-02-12 | |
| S002 | 1980-11-07 | |
| S001 | 1980-11-07 |