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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,RADIESSE (+) LIDOCAINE DERMAL FILLER
Generic NameImplant, dermal, for aesthetic use
ApplicantMerz North America, Inc.
4133 Ct.ney Rd., Suite 10
Franksville, WI 53126
PMA NumberP050052
Supplement NumberS078
Date Received12/07/2015
Decision Date02/22/2016
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for replacing the 28 GA needle with a 27 GA needle in RADIESSE and RADIESSE (+) Lidocaine Kits, and revision to the labeling to reflect the approved 36 month expiration date for 1.5 cc fill volume.
Post-Approval StudyShow Report Schedule and Study Progress
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