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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceMONOVISC
Classification Nameacid, hyaluronic, intraarticular
Generic Nameacid, hyaluronic, intraarticular
Applicant
Anika Therapeutics, Inc.
32 wiggins avenue
bedford, MA 01730
PMA NumberP090031
Date Received12/29/2009
Decision Date02/25/2014
Product Code
MOZ[ Registered Establishments with MOZ ]
Docket Number 14M-0254
Notice Date 03/05/2014
Advisory Committee Orthopedic
Clinical Trials NCT00653432
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE MONOVISC INJECTABLE INTRA-ARTICULAR DEVICE. THIS DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TOCONSERVATIVE NON-PHARMACOLOGIC THERAPY AND TO SIMPLE ANALGESICS (E.G., ACETAMINOPHEN).
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements: S001 S002 S003 S004 S006 S007 
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