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, RHA®4, RHA® Redensity™ Mepi, RHA® 2 Mepi, RHA® 3 Mepi, RHA® 4 Mepi
• Generic Name: Implant, dermal, for aesthetic use
• Applicant: Teoxane S.A.; Les Charmilles Rue De Lyon, 105; Geneva 1203
• PMA Number: P170002
• Supplement Number: S044
• Date Received: 09/19/2024
• Decision Date: 10/18/2024
• Product Code: LMH
• Advisory Committee: General & Plastic Surgery
• Supplement Type: Special (Immediate Track)
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for the implementation of a new inspection step to improve the visual control process.