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 labeling modifications in the package insert
| Device | AOSEPT DISINFECTANT |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | CIBA VISION CARE |
| Date Received | 1995-07-27 |
| Decision Date | 1995-12-13 |
| PMA | P820040 |
| Supplement | S033 |
| Product Code | LPN |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CIBA VISION CARE 11460 Johns Creek Pkwy. duluth, GA 30136-1518 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P820040 | Original Filing | |
| S033 | 1995-07-27 | Normal 180 Day Track |
| S032 | 1994-09-08 | Normal 180 Day Track |
| S031 | 1991-11-05 | Normal 180 Day Track |
| S030 | 1991-09-03 | Normal 180 Day Track |
| S029 | 1990-11-01 | Normal 180 Day Track |
| S028 | ||
| S027 | 1990-05-09 | Normal 180 Day Track |
| S026 | 1990-03-02 | Normal 180 Day Track |
| S025 | 1989-08-29 | Normal 180 Day Track |
| S024 | ||
| S023 | 1989-01-26 | Normal 180 Day Track |
| S022 | 1988-12-08 | Normal 180 Day Track |
| S021 | 1988-11-21 | Normal 180 Day Track |
| S020 | 1988-04-05 | Normal 180 Day Track |
| S019 | 1988-01-27 | Special (immediate Track) |
| S018 | ||
| S017 | 1987-09-08 | Normal 180 Day Track |
| S016 | 1987-08-28 | Normal 180 Day Track |
| S015 | 1987-07-16 | Normal 180 Day Track |
| S014 | 1987-04-13 | Normal 180 Day Track |
| S013 | 1987-04-01 | Normal 180 Day Track |
| S012 | 1986-12-03 | 30-Day Supplement |
| S011 | 1986-06-27 | Normal 180 Day Track |
| S010 | 1986-02-26 | |
| S009 | 1985-10-15 | Normal 180 Day Track |
| S008 | ||
| S007 | 1985-09-30 | |
| S006 | 1985-05-20 | |
| S005 | 1985-05-02 | |
| S004 | 1984-08-30 | |
| S003 | 1984-07-17 | |
| S002 | 1984-01-03 | |
| S001 | 1983-03-24 |