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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.
 
DeviceAQUAFLEX HYDROPHILIC CONTACT LENSES
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCOOPERVISION, INC.
6150 Stoneridge Mall Road
Suite 370
Pleasanton, CA 94588
PMA NumberN17679
Supplement NumberS015
Date Received10/26/1987
Decision Date03/15/1988
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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