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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.
 
DeviceEUFLEXXA
Classification Nameacid, hyaluronic, intraarticular
Generic Nameacid, hyaluronic, intraarticular
Applicant
FERRING PHARMACEUTICALS, INC.
100 interpace parkway
parsippany, NJ 07054
PMA NumberP010029
Supplement NumberS017
Date Received05/08/2013
Decision Date06/04/2013
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
ADD A NEW SYRINGE DENESTER MACHINE AND AN ALTERNATIVE ASSEMBLY AND LABELING MACHINE.
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