Orthovisc, Sodium Hyaluronic

FDA Premarket Approval P030019 S027

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

DeviceOrthovisc, Sodium Hyaluronic
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantAnika Therapeutics, Inc.32 Wiggins Avenuebedford, MA 01730 PMA NumberP030019 Supplement NumberS027 Date Received10/12/2022 Decision Date11/08/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-10-12
Decision Date2022-11-08
PMAP030019
SupplementS027
Product CodeMOZ 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressAnika Therapeutics, Inc.
32 Wiggins Avenue
bedford, MA 01730 PMA NumberP030019 Supplement NumberS027 Date Received10/12/2022 Decision Date11/08/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
the Addition Of An Alternate Supplier Of Fermented Hyaluronic Acid (HA) Raw Material For Orthovisc And Monovisc

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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