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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, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Lidocaine Jawline
Generic NameImplant, dermal, for aesthetic use
ApplicantMerz North America, Inc.
4133 Ct.ney Rd., Suite 10
Franksville, WI 53126
PMA NumberP050052
Supplement NumberS148
Date Received05/09/2023
Decision Date06/08/2023
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate 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 revisions to the clinician labeling and patient labeling as a result of postmarket surveillance data.
Post-Approval StudyShow Report Schedule and Study Progress
  We welcome your comments and feedback about Devices@FDA.
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