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.
| Device | SYSTEM 3 WETTING IN EYE COMFORT DROPS |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1992-05-27 |
| Decision Date | 1993-09-29 |
| PMA | P870029 |
| Supplement | S007 |
| 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 |
|---|---|---|
| P870029 | Original Filing | |
| S009 | 1993-03-19 | Normal 180 Day Track |
| S008 | ||
| S007 | 1992-05-27 | Normal 180 Day Track |
| S006 | ||
| S005 | ||
| S004 | 1990-07-09 | Normal 180 Day Track |
| S003 | 1989-08-21 | Normal 180 Day Track |
| S002 | ||
| S001 |