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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.
 
DeviceHYDRASOFT (METHAFILCON B) CONTACT LENS
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCOOPERVISION, INC.
370 WOODCLIFF DRIVE
SUITE 200
FAIRPORT, NY 14450-0000
PMA NumberP850079
Date Received10/30/1985
Decision Date01/31/1986
Product Code LPM 
Docket Number 86M-0110
Notice Date 03/28/1986
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Supplements:  S001 S002 S003 S004 S005 S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S020 S021 S024 S025 S026 
S027 S028 S029 S030 S031 S032 S034 S036 S037 S038 S039 S040 
S041 S042 S043 S045 S046 S047 S048 S049 S050 S051 S052 S053 
S054 S055 S056 S057 S058 S059 S060 S061 S062 S063 S064 S065 
S067 S068 S069 S070 S071 S072 S073 S074 S075 S076 S077 S078 
S079 S080 S081 S082 S083 S084 S085 S086 S087 S088 S089 
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