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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 NameAMO VITRAX (SODIUM HYALURONATE) VISCOELASTIC SOLUTION
Classification Nameaid, surgical, viscoelastic
Generic Nameviscoelastic solution
Regulation Number886.4275
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP880031
Supplement NumberS013
Date Received10/15/1999
Decision Date11/08/1999
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to 1) extend the finished product uv absorbance specification from 0. 012 au to 0. 016 au and 2) eliminate the uv absorbance specification from the 24 month shelf-life.
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