SINOVIAL (SODIUM HYALURONATE 0.8%)

Acid, Hyaluronic, Intraarticular

FDA Premarket Approval P110005

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for gel-syn. This 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 simple analgesics (e. G. Acetaminophen).

DeviceSINOVIAL (SODIUM HYALURONATE 0.8%)
Classification NameAcid, Hyaluronic, Intraarticular
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantIBSA INSTITUT BIOCHIMIQUE SA
Date Received2011-02-10
Decision Date2014-05-09
Notice Date2014-05-29
PMAP110005
SupplementS
Product CodeMOZ
Docket Number14M-0691
Advisory CommitteeOrthopedic
Expedited ReviewNo
Combination Product No
Applicant Address IBSA INSTITUT BIOCHIMIQUE SA via Al Ponte 13, Ch-6903 lugano Ticino 6903
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P110005Original Filing
S009 2021-03-31 135 Review Track For 30-day Notice
S008 2021-03-03 30-day Notice
S007 2020-12-03 30-day Notice
S006 2020-09-04 30-day Notice
S005 2020-09-04 30-day Notice
S004 2020-06-29 Special (immediate Track)
S003 2018-04-09 Special (immediate Track)
S002 2017-01-19 Normal 180 Day Track
S001 2016-03-25 Real-time Process

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