HYMOVIS

Acid, Hyaluronic, Intraarticular

FDA Premarket Approval P150010 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

Manufacturing process change to preparation of the principal bulk component.

• Device: HYMOVIS
• Classification Name: Acid, Hyaluronic, Intraarticular
• Generic Name: Acid, Hyaluronic, Intraarticular
• Applicant: FIDIA FARMACEUTICI
• Date Received: 2016-10-24
• Decision Date: 2016-11-22
• PMA: P150010
• 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: FIDIA FARMACEUTICI ponte Della Fabbrica 3/a abano Terme 35031

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