|
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 | S019 |
Date Received | 01/14/2009 |
Decision Date | 07/13/2009 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE TO PROVIDE DETAILED INSTRUCTIONS FOR MIXING RADIESSE WITH 2% LIDOCAINE HCL (RESULTING IN A FINAL CONCENTRATION OF 0.3% LIDOCAINE) PRIOR TO INJECTION FOR THE INDICATED USE OF SUBDERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS, SUCH AS NASOLABIAL FOLDS. THE MIXING OF RADIESSE AND LIDOCAINE IS TO BE ACCOMPLISHED USING A MIXING KIT THAT WILL BE MADE AVAILABLE SEPARATE FROM THE RADIESSE DEVICE. |