EUFLEXXA (1% SODIUM HYALURONATE)

Acid, Hyaluronic, Intraarticular

FDA Premarket Approval P010029 S008

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 euflexxa (1% sodium hyaluronate). This device is indicated for the treatment of pain in osteoarthritis (oa) of the knee in patients who have failed to respond adequately to conservativenon-pharmacologic therapy and to simple analgesics (e. G. , acetaminophen).

DeviceEUFLEXXA (1% SODIUM HYALURONATE)
Classification NameAcid, Hyaluronic, Intraarticular
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantFERRING PHARMACEUTICALS, INC.
Date Received2009-03-30
Decision Date2011-10-11
Notice Date2011-10-20
PMAP010029
SupplementS008
Product CodeMOZ
Docket Number11M-0736
Advisory CommitteeOrthopedic
Supplement TypePanel Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address FERRING PHARMACEUTICALS, INC. 100 Interpace Parkway parsippany, NJ 07054
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

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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