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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameMONOVISC
Classification Nameacid, hyaluronic, intraarticular
ApplicantANIKA THERAPEUTICS, INC.
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 to conservative non-pharmacologic therapy and to simple analgesics (e. G. , acetaminophen).
Approval Order Approval Order
Supplements: S001 S002 
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