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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
Applicant
CooperVision, Inc.
6101 bollinger canyon road, 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 Product No
Supplements:  S044 S046 S045 S049 S043 S041 S042 S047 
S040 S039 S038 S037 S036 S035 S034 S033 S032 
S031 S030 S029 S027 S026 S025 S024 S023 S022 
S020 S019 S018 S017 S016 S015 S014 S013 S012 
S011 S010 S009 S008 S007 S005 S004 S003 S002 
S001 S055 S054 S052 S053 S056 S057 S051 
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