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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 Dr., 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
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Supplements: S039 S001 S002 S004 S005 S006 S007 S008 S010 S011 S012 S013 
S014 S017 S018 S019 S040  S031 S024 S026 S041 S022 S036 
S025 S023 S057 S061 S027 S035 S038 S032 S033 S037 S062 S059 
S058 S067 S069 S074 S070 S076 S078 S079 S075 S063 S064 S077 
S082 S034 S028 S029 S030 S054 S055 S056 S052 S048 S046 S042 
S043 S045 S053 S051 S047 S068 S065 S066 S071 S072 S044 S080 
S081 S073 S049 S050 
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