HYMOVIS

Acid, Hyaluronic, Intraarticular

FDA Premarket Approval P150010

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 hymovis. This device is indicated for 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: HYMOVIS
• Classification Name: Acid, Hyaluronic, Intraarticular
• Generic Name: Acid, Hyaluronic, Intraarticular
• Applicant: FIDIA FARMACEUTICI
• Date Received: 2015-02-25
• Decision Date: 2015-08-28
• Notice Date: 2015-10-14
• PMA: P150010
• Supplement: S
• Product Code: MOZ
• Docket Number: 15M-3256
• Advisory Committee: Orthopedic
• Expedited Review: No
• Combination Product: No
• Applicant Address: FIDIA FARMACEUTICI ponte Della Fabbrica 3/a abano Terme 35031
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling Labeling Part 2
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P150010		Original Filing
S002	2022-07-11	30-day Notice
S001	2016-10-24	30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
M71389122049663SAM1	P150010	000
M713891220496010	P150010	000