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: Radiessse Hands, and Radiesse (+) Lidocaine Dermal Filler
• Generic Name: Implant, dermal, for aesthetic use
• Applicant: Merz North America, Inc.; 4133 Ct.ney Rd., Suite 10; Franksville, WI 53126
• PMA Number: P050052
• Supplement Number: S111
• Date Received: 04/19/2019
• Decision Date: 05/17/2019
• 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  
Qualification of a newer model thermal validation system.