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 (+) 0.8CC, RADIESSE (+) 1.5CC
• 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: S073
• Date Received: 09/25/2015
• Decision Date: 05/02/2016
• Product Code: LMH
• Advisory Committee: General & Plastic Surgery
• Supplement Type: 135 Review Track For 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  
Approval for using an alternate supplier for the syringe barrels and assembly of the syringe components.