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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.
 
DeviceSOFLENS CONTACT LENSES (POLYMACON)
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantBausch & Lomb, Inc.
1400 N. Goodman St.
Rochester, NY 14609
PMA NumberN16895
Date Received03/18/1971
Decision Date03/18/1971
Product Code LPM 
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Supplements: S092 S093 S085 S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S017 S018 S019 S020 S021 S023 
S024 S025 S026 S027 S028 S029 S031 S033 S036 S037 S038 S040 
S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 S051 S052 
S053 S054 S055 S056 S057 S058 S059 S060 S061 S062 S063 S064 
S066 S067 S068 S069 S070 S071 S074 S075 S076 S077 S079 S080 
S081 S082 S083 S084  S088 S097 S094 S089 S086 S087 S090 
S091 S098 S099 S102 S103 S104 S105 S101 S100 S095 S096 S106 
S107 
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