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Device | RADIESSE LOW VISCOSITY INJECTABLE IMPLANT; RADIESSE (+) LIDOCAINE DERMANL FILTER |
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 | S076 |
Date Received | 12/02/2015 |
Decision Date | 05/31/2016 |
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 for the following three changes: 1) Qualification testing of the BI spore strips, 2) Bioburden test frequency, and 3) Endotoxin detection limit. |