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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 SODIUM HYALURONATE
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAnika Therapeutics, Inc.
32 WIGGINS AVENUE
BEDFORD, MA 01730
PMA NumberP000046
Supplement NumberS012
Date Received09/07/2005
Decision Date09/26/2005
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE CHANGE IN LABELING TO INCLUDE CANNULA ASSEMBLY INSTRUCTIONS.
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