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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 NameHEALON SODIUM HYALURONATE
Classification Nameaid, surgical, viscoelastic
Regulation Number886.4275
ApplicantPHARMACIA & UPJOHN CO.
PMA NumberP810031
Supplement NumberS024
Date Received07/10/2002
Decision Date07/25/2002
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of the "precaution" section of the package insert to include the following: "before initiating phacoemulsifica-tion, use irrigation/ aspiration to create a fluid-filled space above the lens. This reduces the risk of initial visco-occulsion of the phaco tip or the irrigation line which could cause phaco tip heating. ".
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