ORTHOVISC SODIUM HYALURONATE

FDA Premarket Approval P030019 S009

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 modifying the manufacturing process for orthovisc to one that produces sodium hyaluronate from bacterial fermentation. 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).

DeviceORTHOVISC SODIUM HYALURONATE
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantAnika Therapeutics, Inc.
Date Received2006-04-28
Decision Date2007-10-26
PMAP030019
SupplementS009
Product CodeMOZ 
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Anika Therapeutics, Inc. 32 Wiggins Avenue bedford, MA 01730

Supplemental Filings

Supplement NumberDateSupplement Type
P030019Original Filing
S027 2022-10-12 30-day Notice
S026 2020-12-30 135 Review Track For 30-day Notice
S025 2020-11-09 30-day Notice
S024
S023 2016-02-10 Special (immediate Track)
S022 2014-12-24 135 Review Track For 30-day Notice
S021 2014-06-25 30-day Notice
S020 2014-06-10 30-day Notice
S019 2014-05-15 30-day Notice
S018 2011-08-24 135 Review Track For 30-day Notice
S017 2010-11-03 135 Review Track For 30-day Notice
S016
S015 2010-06-09 30-day Notice
S014 2009-06-16 Normal 180 Day Track No User Fee
S013 2006-07-24 135 Review Track For 30-day Notice
S012 2006-08-09 Normal 180 Day Track
S011
S010 2006-07-10 30-day Notice
S009 2006-04-28 Normal 180 Day Track
S008 2006-01-03 30-day Notice
S007
S006 2004-07-01 Normal 180 Day Track
S005 2004-06-17 30-day Notice
S004 2004-05-07 30-day Notice
S003 2004-03-16 30-day Notice
S002
S001 2004-02-27 135 Review Track For 30-day Notice

NIH GUDID Devices

Device IDPMASupp
05060548950026 P030019 000
05060459970038 P030019 022
00817337000111 P030019 026

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