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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.
 
DeviceMETHAFILCON A AND METHAFILCON B SOFT HYDROPHILIC WEAR CONTACT LENSES INSTALLATION AND VALIDATION OF A NEW 3M ATTEST 290
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCOOPERVISION, INC.
370 WOODCLIFF DRIVE
SUITE 200
FAIRPORT, NY 14450-0000
PMA NumberP850079
Supplement NumberS053
Date Received06/12/2012
Decision Date07/11/2012
Product Code LPM 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ADDITION OF DUPLICATE MICROBIOLOGICAL MANUFACTURING EQUIPMENT.
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