|
Device | Belotero Balance(R) 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 | S034 |
Date Received | 08/22/2019 |
Decision Date | 09/07/2022 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of an alternative contract manufacturer for secondary packaging operations and finished product warehousing and distribution of Belotero Balance. |