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 the unpreserved formulation of consept-2 neutralizing and rinsing solution to be packaged in a non-aerosol multi-dose 8 and 12 fluid pz containers with a filter/valve closure system labeled with a discard date of 60 days
| Device | UNPRESERVED CONSEPT-2 RINSING & NEUTRALIZING SOL. |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1991-10-03 |
| Decision Date | 1996-02-29 |
| PMA | P840066 |
| Supplement | S029 |
| Product Code | LPN |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ADVANCED MEDICAL OPTICS, INC. 2525 Dupont Dr. irvine, CA 92612 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P840066 | Original Filing | |
| S034 | 1996-11-20 | Normal 180 Day Track |
| S033 | 1995-01-27 | Normal 180 Day Track |
| S032 | 1991-11-06 | Normal 180 Day Track |
| S031 | 1991-10-22 | Normal 180 Day Track |
| S030 | 1991-10-08 | Normal 180 Day Track |
| S029 | 1991-10-03 | Normal 180 Day Track |
| S028 | 1991-07-03 | Normal 180 Day Track |
| S027 | 1990-11-21 | Normal 180 Day Track |
| S026 | 1990-06-29 | Normal 180 Day Track |
| S025 | ||
| S024 | 1990-03-27 | Normal 180 Day Track |
| S023 | 1990-02-07 | Normal 180 Day Track |
| S022 | 1990-01-30 | Normal 180 Day Track |
| S021 | 1989-10-12 | Normal 180 Day Track |
| S020 | 1989-09-21 | Normal 180 Day Track |
| S019 | 1989-09-07 | Normal 180 Day Track |
| S018 | 1989-02-06 | Normal 180 Day Track |
| S017 | ||
| S016 | ||
| S015 | 1988-07-28 | Normal 180 Day Track |
| S014 | 1988-06-16 | Normal 180 Day Track |
| S013 | 1988-06-09 | Normal 180 Day Track |
| S012 | 1988-02-26 | Normal 180 Day Track |
| S011 | 1988-02-09 | Normal 180 Day Track |
| S010 | 1988-02-09 | Normal 180 Day Track |
| S009 | 1987-11-19 | Normal 180 Day Track |
| S008 | 1987-10-20 | Normal 180 Day Track |
| S007 | 1987-07-09 | Normal 180 Day Track |
| S006 | 1987-05-15 | Normal 180 Day Track |
| S005 | 1987-04-24 | Normal 180 Day Track |
| S004 | 1986-12-15 | Normal 180 Day Track |
| S003 | ||
| S002 | 1986-11-06 | Normal 180 Day Track |
| S001 |