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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DevicePERMALENS (PERFILCON A) SOFT HYDROPHILIC CONTACT LENS
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCOOPERVISION, INC.
6150 STONERIDGE MALL ROAD
SUITE 500
PLEASANTON, CA 94588
PMA NumberP780010
Date Received11/14/1978
Decision Date06/11/1979
Withdrawal Date06/11/2014
Product Code LPM 
Notice Date 12/28/1979
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Supplements: S020 S022 S002 S008 S010 S011 S012 S013 S014 S015 S016 S017 
S018 S019 S021  
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