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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAMO VITRAX (SODIUM HYALURONATE) VISCOELASTIC SOLUTION
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAbbott Medical Optics, Inc.
1700 E. St. Andrew Pl.
Santa Ana, CA 92705
PMA NumberP880031
Supplement NumberS013
Date Received10/15/1999
Decision Date11/08/1999
Withdrawal Date03/03/2011
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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