Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: SYNVISC AND SYNVISC-ONE
• Classification Name: acid, hyaluronic, intraarticular
• Generic Name: hylan g-f 20
• Applicant: GENZYME CORPORATION
• PMA Number: P940015
• Supplement Number: S022
• Date Received: 09/09/2011
• Decision Date: 10/07/2011
• Product Code: MOZ [ Registered Establishments with MOZ ]
• Advisory Committee: Orthopedic
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Addition of a syringe assembly machine to the packaging department.