|
Device | RADIESSE (+) 1.5CC, RADIESSE (+) 0.8CC |
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 | S067 |
Date Received | 06/09/2015 |
Decision Date | 07/06/2015 |
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 | No |
Approval Order Statement ELIMINATION OF BIOLOGICAL INDICATOR (BI) STERILITY MONITORING OF RADIESSE(+). |