|
Device | RADIESSE INJECTABLE IMPLANT |
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 | S020 |
Date Received | 01/29/2009 |
Decision Date | 02/25/2009 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF A 0.8 CC FILL VOLUME INJECTABLE IMPLANT AND ASSOCIATED LABELING CHANGES. |