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 Injectable Implant
• 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: S096
• Date Received: 07/17/2017
• Decision Date: 09/18/2017
• Product Code: LMH
• Advisory Committee: General & Plastic Surgery
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - OSB
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS) protocol.