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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
Generic Nameacid, hyaluronic, intraarticular
ApplicantFERRING PHARMACEUTICALS, INC.
100 interpace parkway
parsippany, NJ 07054
PMA NumberP010029
Supplement NumberS027
Date Received08/22/2018
Decision Date11/19/2018
Product Code MOZ 
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a minor design and material change to the tip cap of the syringe utilized to inject EUFLEXXA.
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