EUFLEXXA

Acid, Hyaluronic, Intraarticular

FDA Premarket Approval P010029 S002

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.

Pre-market Approval Supplement Details

Approval for changing the trade name o the product from nuflexxa to euflexxa. The device is indicated for the treatment of pain in osteoarthritis (oa) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e. G. , acetaminophen).

DeviceEUFLEXXA
Classification NameAcid, Hyaluronic, Intraarticular
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantFERRING PHARMACEUTICALS, INC.
Date Received2005-10-05
Decision Date2005-10-20
PMAP010029
SupplementS002
Product CodeMOZ
Docket NumberPremarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radia
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address FERRING PHARMACEUTICALS, INC. 100 Interpace Parkway parsippany, NJ 07054

Supplemental Filings

Supplement NumberDateSupplement Type
P010029Original Filing
S030 2020-04-02 30-day Notice
S029 2019-12-09 30-day Notice
S028 2019-04-05 30-day Notice
S027 2018-08-22 Real-time Process
S026 2018-03-29 30-day Notice
S025 2017-06-20 Normal 180 Day Track No User Fee
S024 2015-04-23 30-day Notice
S023 2015-03-06 30-day Notice
S022 2015-02-09 30-day Notice
S021 2014-12-24 30-day Notice
S020 2014-04-28 30-day Notice
S019 2014-02-20 30-day Notice
S018 2013-11-13 30-day Notice
S017 2013-05-08 30-day Notice
S016 2013-01-15 30-day Notice
S015 2012-04-05 30-day Notice
S014 2012-03-05 30-day Notice
S013 2011-12-29 30-day Notice
S012 2011-03-02 30-day Notice
S011 2009-12-07 30-day Notice
S010 2009-11-17 135 Review Track For 30-day Notice
S009 2009-11-09 30-day Notice
S008 2009-03-30 Panel Track
S007 2008-05-02 135 Review Track For 30-day Notice
S006 2007-03-22 Real-time Process
S005
S004 2006-09-18 Real-time Process
S003
S002 2005-10-05 Normal 180 Day Track No User Fee
S001 2005-01-13 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
05060548950064 P010029 000
07640128544210 P010029 001
05060459970045 P010029 024

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