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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceULTRA CARE (TM) NEUTRALIZING TABLET
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantAdvanced Medical Optics, Inc.
2525 Dupont Dr.
Irvine, CA 92612
PMA NumberP850088
Supplement NumberS036
Date Received08/23/1996
Decision Date07/03/1997
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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