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U.S. Department of Health and Human Services

Devices@FDA
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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 Ct.ney Rd., 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
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
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
Post-Approval StudyShow Report Schedule and Study Progress
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