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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.
 
DeviceSYNVISC-ONE
Classification Nameacid, hyaluronic, intraarticular
Generic Nameacid, hyaluronic, intraarticular
Applicant
GENZYME CORP.
55 cambridge parkway
4th floor
cambridge, MA 02142
PMA NumberP940015
Supplement NumberS012
Date Received06/19/2007
Decision Date02/26/2009
Product Code
MOZ[ Registered Establishments with MOZ ]
Docket Number 09M-0128
Notice Date 03/10/2009
Advisory Committee Orthopedic
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE SYNVISC-ONE. THE DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS OF THE KNEE IN PATIENTS WHO HAVE FILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND SIMPLE ANALGESICS, E.G., ACETAMINOPHEN.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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