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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 & SHELLGEL SODIUM HYAURONATE
Classification Nameaid, surgical, viscoelastic
Generic Nameaid,surgical,viscoelastic
Regulation Number886.4275
ApplicantANIKA THERAPEUTICS, INC.
PMA NumberP000046
Supplement NumberS015
Date Received06/10/2009
Decision Date03/27/2012
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site change from the previous facility in west cummings park, woburn, massachusetts to the new facility located in bedford, massachusetts. In addition, the supplement requested approval to change the terminal sterilization method of the product from e-beam controlled depth sterilization to vaporized hydrogen peroxide (vhp) gas sterilization.
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