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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD) HEALON,HEALON GV, AND HEALON5 PRODUCTS
Classification Nameaid, surgical, viscoelastic
Regulation Number886.4275
ApplicantABBOTT MEDICAL OPTICS INC
PMA NumberP810031
Supplement NumberS047
Date Received03/15/2013
Decision Date04/09/2013
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the in-process bioburden testing.
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