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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 NameSTAARVISC II SODIUM HYALURONATE AND SHELLGEL SODIUM HYALURONATE
Classification Nameaid, surgical, viscoelastic
Generic Nameaid, surgical, viscoelastic
Regulation Number886.4275
ApplicantAnika Therapeutics, Inc.
PMA NumberP000046
Supplement NumberS002
Date Received03/18/2002
Decision Date08/30/2002
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an additional cleanroom area.
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