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: JUVEDERM HYALURONATE GEL IMPLANTS
• Classification Name: implant, dermal, for aesthetic use
• Generic Name: juvederm gel implants
• Applicant: ALLERGAN
• PMA Number: P050047
• Supplement Number: S015
• Date Received: 03/09/2011
• Decision Date: 03/25/2011
• Product Code: LMH [ Registered Establishments with LMH ]
• Advisory Committee: General & Plastic Surgery
• Supplement Type: Special Supplement
• Supplement Reason: labeling change - instructions
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement 
Approval for some labeling updates to improve the safe use of the device.