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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceRADIESSE INJECTABLE IMPLANT
Generic Nameimplant, dermal, for aesthetic use in the hands
ApplicantMERZ NORTH AMERICA, INC
4133 courtney road
suite 10
franksville, WI 53126
PMA NumberP050052
Supplement NumberS049
Date Received12/02/2013
Decision Date06/04/2015
Product Codes PKY LMH 
Docket Number 15M-2078
Notice Date 06/05/2015
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT01004107
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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