Orthovisc

FDA Premarket Approval P030019 S026

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

A new rubber stopper formulation for the 3 ml stoppers formulation

DeviceOrthovisc
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantAnika Therapeutics, Inc.
Date Received2020-12-30
Decision Date2021-07-02
PMAP030019
SupplementS026
Product CodeMOZ 
Advisory CommitteeOrthopedic
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Anika Therapeutics, Inc. 32 Wiggins Avenue bedford, MA 01730

Supplemental Filings

Supplement NumberDateSupplement Type
P030019Original Filing
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

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