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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
Classification Nameaid, surgical, viscoelastic
Regulation Number886.4275
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP810031
Supplement NumberS030
Date Received08/14/2006
Decision Date09/13/2006
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Relocation of a quality control laboratory used for incoming inspection of raw materials (except sodium hyaluronate) and packaging components for healon products to a different building at the same manufacturing site in the uppsala, sweden facility.
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