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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.
 
DeviceSTAARVISC II & SHELLGEL SODIUM HYAURONATE
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAnika Therapeutics, Inc.
32 WIGGINS AVENUE
BEDFORD, MA 01730
PMA NumberP000046
Supplement NumberS015
Date Received05/27/2009
Decision Date03/27/2012
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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