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 sue of 100% ethylene oxide to sterilize plastic bottles, tips, and caps used in the mnaufacture of the device
| Device | ALLERGAN(R) PRESERVED SALINE SOL.SPEC CHANGE |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1995-06-08 |
| Decision Date | 1996-02-23 |
| PMA | N18020 |
| Supplement | S041 |
| 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 |
|---|---|---|
| N18020 | Original Filing | |
| S041 | 1995-06-08 | Normal 180 Day Track |
| S040 | 1995-05-30 | Normal 180 Day Track |
| S039 | 1995-05-05 | Normal 180 Day Track |
| S038 | 1993-03-19 | Normal 180 Day Track |
| S037 | 1990-10-31 | Normal 180 Day Track |
| S036 | 1990-10-09 | Normal 180 Day Track |
| S035 | 1990-09-12 | Normal 180 Day Track |
| S034 | 1990-07-12 | Normal 180 Day Track |
| S033 | 1990-01-23 | Normal 180 Day Track |
| S032 | 1989-12-04 | Normal 180 Day Track |
| S031 | 1989-10-26 | Normal 180 Day Track |
| S030 | 1989-09-29 | Normal 180 Day Track |
| S029 | 1989-05-31 | Normal 180 Day Track |
| S028 | 1989-04-03 | Normal 180 Day Track |
| S027 | 1989-01-06 | Normal 180 Day Track |
| S026 | 1988-05-27 | Normal 180 Day Track |
| S025 | 1988-04-14 | Normal 180 Day Track |
| S024 | 1988-01-25 | Normal 180 Day Track |
| S023 | 1987-10-20 | Normal 180 Day Track |
| S022 | 1987-03-16 | 30-Day Supplement |
| S021 | ||
| S020 | 1987-01-27 | Normal 180 Day Track |
| S019 | 1984-09-05 | |
| S018 | ||
| S017 | 1984-06-04 | |
| S016 | 1984-04-23 | |
| S015 | 1983-11-01 | |
| S014 | 1982-12-07 | |
| S013 | 1982-04-30 | |
| S012 | 1982-04-12 | |
| S011 | 1981-06-22 | |
| S010 | 1980-12-15 | |
| S009 | ||
| S008 | ||
| S007 | 1980-05-05 | |
| S006 | 1980-09-23 | |
| S005 | 1980-09-23 | |
| S004 | 1980-01-15 | |
| S003 | 1980-01-02 | |
| S002 | 1979-08-17 | |
| S001 |