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: RADIESSE Implant
• Generic Name: Implant, dermal, for aesthetic use
• Applicant: Merz North America, Inc.; 4133 Ct.ney Rd., Suite 10; Franksville, WI 53126
• PMA Number: P050037
• Supplement Number: S112
• Date Received: 09/21/2021
• Decision Date: 10/21/2021
• 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: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for inclusion of additional elemental impurities testing in accordance with USP <232>.