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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 NameSYNVISC, SYNVISC-ONE
Classification Nameacid, hyaluronic, intraarticular
Generic Namehylan g-f 20
ApplicantGENZYME CORP.
PMA NumberP940015
Supplement NumberS033
Date Received07/09/2014
Decision Date08/21/2014
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Orthopedic
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the updating of the package insert and patient information leaflet with respect to adverse event information on pseudosepsis, allergic reactions, and hypersensitivity.
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