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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceTETRAFILCON LENSES: PREFERENCE SPHERE
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
Applicant
COOPERVISION, INC.
6150 stoneridge mall road
suite 370
pleasanton, CA 94588
PMA NumberN17679
Supplement NumberS036
Date Received08/19/2013
Decision Date09/13/2013
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 to the sterilization cycle.
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