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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
ApplicantMERZ NORTH AMERICA, INC
4133 courtney road
suite 10
franksville, WI 53126
PMA NumberP050052
Supplement NumberS129
Date Received12/03/2020
Decision Date09/01/2021
Product Code LMH 
Docket Number 21M-0975
Notice Date 09/03/2021
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT02904057
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for Radiesse (+) injectable implant for expanding the indications to include deep injection (subdermal and/or supraperiosteal) for soft tissue augmentation to improve moderate to severe loss of jawline contour in adults over the age of 21
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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