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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.
Classification Namelenses, soft contact, extended wear
Generic Namehydrophilic for ext wear
Regulation Number886.5925
PMA NumberP830037
Date Received07/07/1983
Decision Date04/24/1984
Product Code
LPM[ Registered Establishments with LPM ]
Docket Number 84M-0164
Notice Date 05/31/1984
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the durasoft 3 (phemfilcon a) extended wear hydrophilic contact lens. The lens is indicated for up to 14 days of continuous wear between cleaning and disinfection (extended wear) by persons with eyes that are non-diseased, not-aphakic, have no more than 2. 00 diopters (d) of astigmatism, and require a spherical lens in the power range from -20. 00 d to +0. 00 d for the correction of nearsightedness (myopia) or farsightedness (hyperopia). The lens is to be disinfected using either a heat (thermal) or a chemical (not heat) disinfection system.
Supplements: S001 S003 S004 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S018 S019 S020 
S021 S022 S023 S024 S025 S026 S027 S028 S029 
S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S043 S044 S045 S046 S047 
S048 S051 S052 S053 S054