|
Device | RADIESSE Injectable Implant |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | MERZ NORTH AMERICA, INC 4133 COURTNEY ROAD SUITE 10 FRANKSVILLE, WI 53126 |
PMA Number | P050037 |
Supplement Number | S110 |
Date Received | 11/20/2020 |
Decision Date | 08/27/2021 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for modification of the Calcium Hydroxylapatite (CaHA) particle manufacturing process to allow for an Alternate Processing Pathway (APP) to process CaHA particle byproducts. |