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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameULTRA CARE (TM) NEUTRALIZING TABLET
Classification Nameaccessories, soft lens products
Generic Namedisinfecting solution
Regulation Number886.5928
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP850088
Supplement NumberS036
Date Received08/23/1996
Decision Date07/03/1997
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate formulation using catalase raw material derived from a non-animal source and an associated change in the minimum neutralization soak time from 2 to 4 hours. The alternate formulation includes no changes in the indications for use.
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