MONOVISC INJECTABLE INTRA-ARTICULAR DEVICE

Acid, Hyaluronic, Intraarticular

FDA Premarket Approval P090031 S001

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

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• Device: MONOVISC INJECTABLE INTRA-ARTICULAR DEVICE
• Classification Name: Acid, Hyaluronic, Intraarticular
• Generic Name: Acid, Hyaluronic, Intraarticular
• Applicant: Anika Therapeutics, Inc.
• Date Received: 2014-05-08
• Decision Date: 2014-06-06
• PMA: P090031
• Supplement: S001
• Product Code: MOZ
• Advisory Committee: Orthopedic
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: Anika Therapeutics, Inc. 32 Wiggins Avenue bedford, MA 01730

Supplemental Filings

Supplement Number	Date	Supplement Type
P090031		Original 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 ID	PMA	Supp
05060548950033	P090031	000
05060459970090	P090031	000