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 allergan, 8301 mars dr. , waco, tx 76712 as an alternate manufacturing site
| Device | COMFORTCARE GP(R) WETTING AND SOAKING SOLUTION |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1997-01-17 |
| Decision Date | 1997-02-13 |
| PMA | P820053 |
| Supplement | S025 |
| Product Code | LPN |
| Docket Number | N |
| 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 |
|---|---|---|
| P820053 | Original Filing | |
| S025 | 1997-01-17 | Normal 180 Day Track |
| S024 | ||
| S023 | 1995-01-27 | Normal 180 Day Track |
| S022 | 1992-12-11 | Normal 180 Day Track |
| S021 | 1992-10-26 | Normal 180 Day Track |
| S020 | 1992-02-03 | Normal 180 Day Track |
| S019 | ||
| S018 | 1990-11-21 | Normal 180 Day Track |
| S017 | ||
| S016 | 1990-03-27 | Normal 180 Day Track |
| S015 | 1990-01-30 | Normal 180 Day Track |
| S014 | 1989-10-12 | Normal 180 Day Track |
| S013 | 1989-09-07 | Normal 180 Day Track |
| S012 | 1989-05-09 | Normal 180 Day Track |
| S011 | 1989-03-29 | Normal 180 Day Track |
| S010 | 1988-09-19 | Normal 180 Day Track |
| S009 | 1987-04-13 | Normal 180 Day Track |
| S008 | 1987-01-13 | Normal 180 Day Track |
| S007 | 1987-01-05 | Normal 180 Day Track |
| S006 | 1986-11-06 | 30-Day Supplement |
| S005 | ||
| S004 | 1986-01-21 | |
| S003 | 1985-08-12 | |
| S002 | 1985-05-15 | |
| S001 | 1984-03-22 |