Monovisc High Molecular Weight Hyaluronan

FDA Premarket Approval P090031 S014

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 NumberS014 Date Received10/03/2022 Decision Date11/04/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-10-03
Decision Date2022-11-04
PMAP090031
SupplementS014
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 NumberS014 Date Received10/03/2022 Decision Date11/04/2022 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  
changes To In-process Testing And Final Formulation Steps In The Product Manufacturing Process

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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