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: RHA® Redensity™, RHA®2, RHA®3 and RHA®4 dermal fillers
• Generic Name: Implant, dermal, for aesthetic use
• Applicant: Teoxane S.A.; Les Charmilles Rue De Lyon, 105; Geneva 1203
• PMA Number: P170002
• Supplement Number: S029
• Date Received: 03/31/2023
• Decision Date: 04/14/2023
• 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  
Changes to the manufacturing process to support increased batch production.