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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 Ave.
Beford, MA 01730
PMA NumberP090031
Supplement NumberS003
Date Received11/07/2014
Decision Date02/04/2015
Product Code MOZ 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO EXPAND THE SPECIFICATION FOR RESIDUAL METHANOL INMONOVISC FROM <= 0.05% TO <= 0.03% W/W TO BE IN ACCORDANCE WITH RESIDUAL SOLVENT TESTING LIMITS UNDER USP GENERAL CHAPTER <467>, TO REVISE THE STABILITY TESTING PROTOCOL FOR MONOVISC, AND TO EXTEND THE SHELF LIFE OF MONOVISC FROM 2 YEARS TO 3 YEARS UTILIZING THIS REVISED STABILITY TESTINGPROTOCOL.
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