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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 NumberS162
Date Received05/22/2024
Decision Date03/31/2026
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for expanding the indications of Radiesse Injectable Implant diluted 1:2 with 0.9% sterile saline solution for subdermal implantation for the correction of décolleté wrinkles in patients 22 years of age and older.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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