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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 0.8CC, RADIESSE 1.5CC, RADIESSE 3.0 CC
Generic NameImplant, dermal, for aesthetic use
ApplicantMerz North America, Inc.
4133 Ct.ney Rd., Suite 10
Franksville, WI 53126
PMA NumberP050052
Supplement NumberS057
Date Received07/23/2014
Decision Date08/19/2014
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
RELOCATION OF THE QUALITY INCOMING INSPECTION LAB, INSTALLATION OF THE QC CLEAN ROOM AND INSTALLATION OF AN AUTOMATED TEMPERATURE/HUMIDITY MONITORING SYSTEM.
Post-Approval StudyShow Report Schedule and Study Progress
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