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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameCOMPLETE BRAND LUBRICATING AND REWETTING DROPS
Classification Nameaccessories, soft lens products
Generic Namelubricating and rewetting drops
Regulation Number886.5928
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP910075
Supplement NumberS009
Date Received09/06/1996
Decision Date09/24/1996
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
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).
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