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 | WET-N-SOAK(TM) REWETTING DROPS |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1994-01-21 |
| Decision Date | 1994-04-05 |
| PMA | P900047 |
| Supplement | S002 |
| 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 |
|---|---|---|
| P900047 | Original Filing | |
| S005 | 1996-03-01 | Normal 180 Day Track |
| S004 | 1995-06-08 | Normal 180 Day Track |
| S003 | 1995-05-05 | Normal 180 Day Track |
| S002 | 1994-01-21 | Normal 180 Day Track |
| S001 |