Premarket Approval (PMA)

Note: 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.

• Device: Juvéderm Injectable Gel Implants
• Generic Name: Implant, dermal, for aesthetic use
• Applicant: Allergan; 2525 Dupont Dr.; Irvine, CA 92612
• PMA Number: P050047
• Supplement Number: S078
• Date Received: 09/29/2020
• Decision Date: 10/28/2020
• Product Code: LMH
• Advisory Committee: General & Plastic Surgery
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Change to the cleaning method of process equipment used during the manufacturing of Juvéderm injectable gel products.