|
Device | Belotero Balance + Lidocaine Dermal Filler, Belotero Balance 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 | S044 |
Date Received | 05/04/2021 |
Decision Date | 12/08/2021 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the removal of protein content as part of release and shelf-life specification of Belotero Balance and Belotero Balance (+) Lidocaine. |