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: PREVELLE SILK & HYLAN B GEL
• Classification Name: implant, dermal, for aesthetic use
• Generic Name: hylan b gel
• Applicant: GENZYME BIOSURGERY
• PMA Number: P030032
• Supplement Number: S009
• Date Received: 09/11/2009
• Decision Date: 10/09/2009
• Product Code: LMH [ Registered Establishments with LMH ]
• Advisory Committee: General & Plastic Surgery
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Change in solution sampling and a change in silk bulk production.