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: Bellafill Dermal Filler
• Generic Name: implant, dermal, for aesthetic use
• Applicant: SUNEVA MEDICAL, INC.; 5879 pacific center blvd.; san diego, CA 92121
• PMA Number: P020012
• Supplement Number: S015
• Date Received: 09/01/2017
• Decision Date: 09/28/2017
• 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: No

Approval Order Statement  
Removal of redundant quality control tests for SAN 8250 In-Process Tests with respect to PMMA.