|
Device | RADIESSE (+) Lidocaine Derma 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 | S094 |
Date Received | 06/01/2017 |
Decision Date | 06/27/2017 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Installation of an alternate X-Ray Diffraction unit at Merz North America Quality Lab. |