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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.
 
DevicePERMAFLEX (SURFILCON A)(VASURFILCON A)
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantADVANCED MEDICAL OPTICS, INC.
1700 EAST ST. ANDREW PL.
SANTA ANA, CA 92705
PMA NumberP790020
Date Received09/04/1979
Decision Date04/07/1980
Withdrawal Date 07/19/2006
Product Code LPM 
Docket Number 85M-0167
Notice Date 09/16/1980
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Supplements:  S001 S002 S003 S004 S005 S006 S008 S009 S010 S011 S012 
S013 S015 S017 S018 S019 S021 S022 S023 S024 S025 S027 S028 
S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 
S041 S042 S043 S044 S046 S047 S049 S050 S051 S053 S054 S056 
S057 S058 S059 
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