|
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 | S007 |
Date Received | 05/02/1996 |
Decision Date | 09/13/1996 |
Product Code |
LPN |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A FORMULA MODIFICATION THAT INCLUDES THE ADDTION OF HYDROXYPROPYL METHYLCELLULOSE TO THE FORMULATION OF THE DEVICE. THE INDICATIONS FOR USE REMAIN UNCHANGED |