|
Device | Radiesse Injectable Implant and Radiesse (+) Lidocaine Dermal Filler |
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 | S116 |
Date Received | 10/23/2019 |
Decision Date | 12/21/2020 |
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 | Yes |
Approval Order Statement Approval to implement campaign filling of up to six gel bowls into a single lot of sterilized units for the Radiesse and Radiesse (+) Lidocaine injectable implant products. |