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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.
 
DeviceMONOVISC
Generic NameAcid, hyaluronic, intraarticular
ApplicantAnika Therapeutics, Inc.
32 WIGGINS AVENUE
BEDFORD, MA 01730
PMA NumberP090031
Supplement NumberS006
Date Received02/10/2016
Decision Date02/25/2016
Product Code MOZ 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for adding the following language to the Instructions for Use (IFU): “Intra-articular injection of sodium hyaluronate preparations has occasionally been associated with allergic/anaphylactic reactions and transient hypotension, which have generally resolved spontaneously or after conservative treatment.”
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