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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 NameHEALON, HEALON GV, HEALON5 PRODUCTS SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
Classification Nameaid, surgical, viscoelastic
Generic Namesodium hyaluronate
Regulation Number886.4275
ApplicantABBOTT MEDICAL OPTICS INC
PMA NumberP810031
Date Received07/07/1981
Decision Date01/14/1983
Product Code
LZP[ Registered Establishments with LZP ]
Docket Number 83M-0022
Notice Date 02/08/1983
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product Yes
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 
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