|
Device | Belotero Balance Dermal Filler & Belotero Balance(+) L1docame Dermal Filler |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | MERZ NORTH AMERICA, INC 4133 COURTNEY ROAD SUITE 10 FRANKSVILLE, WI 53126 |
PMA Number | P090016 |
Supplement Number | S057 |
Date Received | 02/20/2024 |
Decision Date | 03/20/2024 |
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 |
Approval Order Statement Change to the assay of residual concentration of BDDE. |