Monovisc High Molecular Weight Hyaluronan

FDA Premarket Approval P090031 S011

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

Alternate plastic formulation for components of the syringe.

DeviceMonovisc High Molecular Weight Hyaluronan
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantAnika Therapeutics, Inc.
Date Received2021-09-15
Decision Date2021-10-13
PMAP090031
SupplementS011
Product CodeMOZ 
Advisory CommitteeOrthopedic
Supplement Type30-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
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

© 2023 FDA.report
This site is not affiliated with or endorsed by the FDA.