Monovisc High Molecular Weight Hyaluronan

FDA Premarket Approval P090031 S015

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

DeviceMonovisc High Molecular Weight Hyaluronan
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantAnika Therapeutics, Inc.32 Wiggins Avenuebedford, MA 01730 PMA NumberP090031 Supplement NumberS015 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
PMAP090031
SupplementS015
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 NumberP090031 Supplement NumberS015 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
P090031Original Filing
S015 2022-10-12 30-day Notice
S014 2022-10-03 30-day Notice
S013 2022-06-17 30-day Notice
S012 2021-09-15 30-day Notice
S011 2021-09-15 30-day Notice
S010 2021-08-11 30-day Notice
S009 2019-07-19 Normal 180 Day Track
S008 2017-05-23 Real-time Process
S007 2016-08-24 30-day Notice
S006 2016-02-10 Special (immediate Track)
S005
S004 2014-12-24 135 Review Track For 30-day Notice
S003 2014-11-07 Real-time Process
S002 2014-06-10 30-day Notice
S001 2014-05-08 30-day Notice

NIH GUDID Devices

Device IDPMASupp
05060548950033 P090031 000
05060459970090 P090031 000

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