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.
Alternate manufacturing site:allergan optical, 8301 mars drive, waco, texas 76712. The device, as modified, will be marketed under the trade name claris cleaning and soaking solution
| Device | CLARIS(R) CLEANING AND SOAKING SOLUTION |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1996-03-01 |
| Decision Date | 1996-07-12 |
| PMA | P870023 |
| Supplement | S007 |
| 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 | ADVANCED MEDICAL OPTICS, INC. 2525 Dupont Dr. irvine, CA 92612 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P870023 | Original Filing | |
| S007 | 1996-03-01 | Normal 180 Day Track |
| S006 | ||
| S005 | 1993-03-10 | Normal 180 Day Track |
| S004 | ||
| S003 | 1992-05-27 | Normal 180 Day Track |
| S002 | 1989-07-31 | Normal 180 Day Track |
| S001 |