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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.
 
DeviceSUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN
Generic NameLenses, soft contact, daily wear
Regulation Number886.5925
ApplicantCOOPER VISION, INC.
6150 Stoneridge Mall Road
Suite 370
Pleasanton, CA 94588
PMA NumberP850077
Supplement NumberS019
Date Received01/26/1994
Decision Date04/28/1995
Withdrawal Date 05/01/2014
Product Code LPL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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