TriVisc

FDA Premarket Approval P160057 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

Approval for revision of the instructions for administration of trivisc to help prevent any leakage of the product during administration.

• Device: TriVisc
• Generic Name: Acid, Hyaluronic, Intraarticular
• Applicant: ORTHOGENRX,INC
• Date Received: 2020-05-08
• Decision Date: 2020-06-07
• PMA: P160057
• Supplement: S001
• Product Code: MOZ
• Advisory Committee: Orthopedic
• Supplement Type: Special (immediate Track)
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: No
• Applicant Address: ORTHOGENRX,INC 3805 Old Easton Road doylestown, PA 18902-8400

Supplemental Filings

Supplement Number	Date	Supplement Type
P160057		Original Filing
S001	2020-05-08	Special (immediate Track)

NIH GUDID Devices

Device ID	PMA	Supp
10850653006044	P160057	000
10193493000767	P160057	002