Monovisc High Molecular Weight Hyaluronan

FDA Premarket Approval P090031 S010

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

An alternate supplier of the glass syringes used in manufacture of the 5ml sizes of monovisc

DeviceMonovisc High Molecular Weight Hyaluronan
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantAnika Therapeutics, Inc.
Date Received2021-08-11
Decision Date2021-09-03
PMAP090031
SupplementS010
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
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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