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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.
 
DeviceMURINE LUBRICATING & REWETTING DROPS(CLEAR EYES )
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantAbbott Laboratories
625 Cleveland Ave.
Columbus, OH 43215
PMA NumberP880056
Supplement NumberS002
Date Received08/13/1992
Decision Date04/14/1994
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
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