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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, extended wear
ApplicantCOOPER VISION, INC.
6150 Stoneridge Mall Road
Suite 370
Pleasanton, CA 94588
PMA NumberP850077
Supplement NumberS020
Date Received09/27/1994
Decision Date05/05/1995
Withdrawal Date 05/01/2014
Product Codes LPL 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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