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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.
 
DeviceHEALON, HEALON GV, HEALON5 PRODUCTS SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
Generic Nameaid, surgical, viscoelastic
Regulation Number886.4275
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 technology drive
suite 200
irvine, CA 92618
PMA NumberP810031
Date Received07/07/1981
Decision Date01/14/1983
Product Code LZP 
Docket Number 83M-0022
Notice Date 02/08/1983
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Supplements:  S001 S002 S004 S005 S006 S007 S008 S010 S011 S012 S013 
S014 S017 S018 S019 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 S049 S050 S051 S052 S053 
S054 S055 S056 S057 S058 S059 S061 S062 S063 S064 S065 S066 
S067 S068 S069 S070 S071 S072 S074 
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