|
Device | RADIESSE INJECTABLE IMPLANT |
Generic Name | Implant, dermal, for aesthetic use in the hands |
Applicant | MERZ NORTH AMERICA, INC 4133 COURTNEY ROAD SUITE 10 FRANKSVILLE, WI 53126 |
PMA Number | P050052 |
Supplement Number | S049 |
Date Received | 12/02/2013 |
Decision Date | 06/04/2015 |
Product Codes |
LMH PKY |
Docket Number | 15M-2078 |
Notice Date | 06/05/2015 |
Advisory Committee |
General & Plastic Surgery |
Clinical Trials | NCT01004107
|
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE RADIESSE® INJECTABLE IMPLANT. THE DEVICE IS INDICATED FOR HAND AUGMENTATION TO CORRECT VOLUME LOSS IN THE DORSUM OF THE HANDS |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |