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: Belotero Balance + Lidocaine
• Generic Name: Implant, dermal, for aesthetic use
• Applicant: Merz North America, Inc.; 4133 Ct.ney Rd., Suite 10; Franksville, WI 53126
• PMA Number: P090016
• Supplement Number: S046
• Date Received: 09/15/2021
• Decision Date: 10/13/2021
• 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: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Qualification of an alternative supplier of needles and modification of associated secondary packaging components to accommodate the new needles.