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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)
Classification Nameaid, surgical, viscoelastic
Regulation Number886.4275
ApplicantABBOTT MEDICAL OPTICS INC
PMA NumberP810031
Supplement NumberS039
Date Received06/23/2011
Decision Date07/21/2011
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 the test method for bioburden testing of finished product prior to moist heat sterilization.
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