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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.
 
DeviceCLARIS(R) CLEANING AND SOAKING SOLUTION
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantAdvanced Medical Optics, Inc.
2525 Dupont Dr.
Irvine, CA 92612
PMA NumberP870023
Supplement NumberS007
Date Received03/01/1996
Decision Date07/12/1996
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ALTERNATE MANUFACTURING SITE:ALLERGAN OPTICAL, 8301 MARS DRIVE, WACO, TEXAS 76712. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CLARIS CLEANING AND SOAKING SOLUTION
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