|
Device | COMPLETE BRAND LUBRICATING AND REWETTING DROPS |
Generic Name | Accessories, soft lens products |
Regulation Number | 886.5928 |
Applicant | ADVANCED MEDICAL OPTICS, INC. 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P910075 |
Supplement Number | S009 |
Date Received | 09/06/1996 |
Decision Date | 09/24/1996 |
Product Code |
LPN |
Advisory Committee |
Ophthalmic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR USE OF A NEW METHOD TO ASSAY THE ACTIVE INGREDIENT, POLYHEXAMETHYLENE BIGUANIDE (PHMB) |