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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.
 
DeviceOCUCOAT(2%HYDROXYPROPYLMETHYLCELLULOSE SOLUTION)
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantBausch & Lomb, Inc.
50 Technology Drive
Irvine, CA 92618
PMA NumberP860047
Supplement NumberS012
Date Received03/20/2003
Decision Date04/16/2003
Product Code LZP 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN THE FREQUENCY OF THE FOLLOWING INCOMING INSPECTION TESTS: HPMC CONTENT, TOTAL CHLORIDES, OSMOLARITY, PARTICULATES, PROTEIN, DENSITY, HPMC VOLUME, PH AND VISCOSITY.
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