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 modifications to the currently approved aosept lens cup and aodisc neutralizer to inlcude a cup manufacturing site change, cup material change, cup and disc design change, and corresponding labeling changes. The new primary manufacturing site is tenax corporation, 124 franklin park avenue, youngsville, nc 27596. Secondary manufacturing site is tenax corp, 2450 laura duncan road, apex, nc 27502
| Device | AOSEPT (R) LENS CUP & AODISC NEUTRALIZER |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | CIBA VISION CARE |
| Date Received | 1994-09-08 |
| Decision Date | 1995-10-23 |
| PMA | P820040 |
| Supplement | S032 |
| 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 | 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 |