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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMONOVISC
Classification Nameacid, hyaluronic, intraarticular
ApplicantANIKA THERAPEUTICS, INC.
PMA NumberP090031
Supplement NumberS003
Date Received11/10/2014
Decision Date02/04/2015
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to expand the specification for residual methanol in monovisc 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 testing protocol.
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