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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.
 
DeviceANIKA VISC
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAnika Therapeutics, Inc.
32 WIGGINS AVENUE
BEDFORD, MA 01730
PMA NumberP000046
Supplement NumberS019
Date Received11/01/2010
Decision Date01/24/2011
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A NEW TRADE NAME. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANIKAVISC AND IS INDICATED FOR USE DURING SURGERY IN THE ANTERIOR AND POSTERIOR SEGMENTS OF THE HUMAN EYE.
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