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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NamePERMAFLEX (SURFILCON A)(VASURFILCON A)
Classification Namelenses, soft contact, extended wear
Generic Namelidofilcon b hydrophilic contact lens
Regulation Number886.5925
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP790020
Date Received09/04/1979
Decision Date11/07/1996
Withdrawal Date 07/19/2006
Product Code
LPM[ Registered Establishments with LPM ]
Docket Number 85M-0167
Notice Date 09/16/1980
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
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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