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 use of a new method to assay the active ingredient, polyhexamethylene biguanide (phmb)
| Device | COMPLETE BRAND LUBRICATING AND REWETTING DROPS |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1996-09-06 |
| Decision Date | 1996-09-24 |
| PMA | P910075 |
| Supplement | S009 |
| Product Code | LPN |
| Advisory Committee | Ophthalmic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Process 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 |
|---|---|---|
| P910075 | Original Filing | |
| S009 | 1996-09-06 | Special (immediate Track) |
| S008 | 1996-07-11 | |
| S007 | 1996-05-02 | Normal 180 Day Track |
| S006 | 1995-06-08 | Normal 180 Day Track |
| S005 | 1995-05-05 | Normal 180 Day Track |
| S004 | 1995-04-06 | Normal 180 Day Track |
| S003 | 1995-02-02 | Normal 180 Day Track |
| S002 | 1993-08-02 | Normal 180 Day Track |
| S001 | 1994-06-30 | Normal 180 Day Track |