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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.
 
DeviceFLUOROPERM RGP CONTACT LENSES
Generic NameLens, contact (rigid gas permeable), extended wear
Regulation Number886.5916
ApplicantCooperVision, Inc.
6101 Bollinger Canyon Rd.
Suite 500
San Ramon, CA 94583
PMA NumberP870024
Date Received05/20/1987
Decision Date12/31/1987
Product Code MWL 
Docket Number 88M-0013
Notice Date 02/22/1988
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Supplements:  S001 S002 S003 S004 S005 S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S020 S022 S023 S024 S025 
S026 S027 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S043 S044 S045 S046 S047 S049 S051 S052 
S053 S054 S055 S056 S057 S058 S059 S060 S062 
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