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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(TM) REWETTING DROPS
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantAdvanced Medical Optics, Inc.
2525 Dupont Dr.
Irvine, CA 92612
PMA NumberP900047
Supplement NumberS005
Date Received03/01/1996
Decision Date06/20/1996
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO 1)DUPLICATE WET-N-SOAK REWETTING DROPS UNDER THE TRADE NAME CLARIS REWETTING DROPS TO BE USED WITH CLARIS CLEANING AND SOAKING SOLUTION (ALLERGAN'S TRADE NAME FOR DESTAT 4 CLEANING, DISINFECTING, STORAGE SOLUTION (P870023)) AND 2)ADD THE FOLLOWING TO THE DIRECTIONS SECTION FOR CLARIS REWETTING DROPS: BEFORE WEARING LENSES: PLACE 1 OR 2 DROPS OF CLARIS REWETTING DROPS ON EACH SIDE OF EACH LENS BEFORE APPLICATION
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