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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 DEVOCES (OVD), HEALON GV, HEALON5 PRODUCTS
Classification Nameaid, surgical, viscoelastic
Regulation Number886.4275
ApplicantABBOTT MEDICAL OPTICS INC
PMA NumberP810031
Supplement NumberS038
Date Received09/03/2010
Decision Date11/22/2010
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a labeling change to update the labeling that was approved under pma supplement p810031/s017 to reflect the abbott branding guidelines.
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