ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN

Acid, Hyaluronic, Intraarticular

FDA Premarket Approval P030019

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the orthovisc high molecular weight hyaluronan. The device is indicated fo the treatment of pain in osteoarthritis (oa) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e. G. , acetaminophen).

• Device: ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN
• Classification Name: Acid, Hyaluronic, Intraarticular
• Generic Name: Acid, Hyaluronic, Intraarticular
• Applicant: Anika Therapeutics, Inc.
• Date Received: 2003-05-30
• Decision Date: 2004-02-04
• Notice Date: 2006-08-24
• PMA: P030019
• Supplement: S
• Product Code: MOZ
• Docket Number: 06M-0339
• Advisory Committee: Orthopedic
• Expedited Review: No
• Combination Product: No
• Applicant Address: Anika Therapeutics, Inc. 32 Wiggins Avenue bedford, MA 01730
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling Labeling Part 2
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P030019		Original Filing
S027	2022-10-12	30-day Notice
S026	2020-12-30	135 Review Track For 30-day Notice
S025	2020-11-09	30-day Notice
S024
S023	2016-02-10	Special (immediate Track)
S022	2014-12-24	135 Review Track For 30-day Notice
S021	2014-06-25	30-day Notice
S020	2014-06-10	30-day Notice
S019	2014-05-15	30-day Notice
S018	2011-08-24	135 Review Track For 30-day Notice
S017	2010-11-03	135 Review Track For 30-day Notice
S016
S015	2010-06-09	30-day Notice
S014	2009-06-16	Normal 180 Day Track No User Fee
S013	2006-07-24	135 Review Track For 30-day Notice
S012	2006-08-09	Normal 180 Day Track
S011
S010	2006-07-10	30-day Notice
S009	2006-04-28	Normal 180 Day Track
S008	2006-01-03	30-day Notice
S007
S006	2004-07-01	Normal 180 Day Track
S005	2004-06-17	30-day Notice
S004	2004-05-07	30-day Notice
S003	2004-03-16	30-day Notice
S002
S001	2004-02-27	135 Review Track For 30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
05060548950026	P030019	000
05060459970038	P030019	022
00817337000111	P030019	026