|
Device | Radiesse Injectable Implant and Radiesse Hands |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | MERZ NORTH AMERICA, INC 4133 COURTNEY ROAD SUITE 10 FRANKSVILLE, WI 53126 |
PMA Number | P050052 |
Supplement Number | S130 |
Date Received | 12/23/2020 |
Decision Date | 06/08/2021 |
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 | No |
Approval Order Statement Approval for the change in mixing the gel and media in a larger mixing bowl rather than multiple smaller mixing bowls during manufacturing of Radiesse Injectable Implant. |