|
Device | RADIESSE 0.8cc and 1.5cc |
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 | S089 |
Date Received | 04/02/2018 |
Decision Date | 08/12/2018 |
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 optimization and scale-up of the Calcium Hydroxylapatite particle manufacturing process. |