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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.
 
DeviceXCEL TORIC (METHAFILCON A) SOFT CONTACT LENS
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
Applicant
COOPERVISION, INC.
370 woodcliff drive
suite 200
fairport, NY 14450-0000
PMA NumberP850079
Supplement NumberS049
Date Received01/28/2011
Decision Date03/16/2011
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE IN LOCATION OF THE WET PROCESSING AREA AND THE USE OF AN ALTERNATE BIOLOGICAL INDICATOR FOR STERILIZATION RELEASE.
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