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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, 1.3 CC AND 0.3 CC
Generic NameImplant, dermal, for aesthetic use
ApplicantMerz North America, Inc.
4133 Ct.ney Rd., Suite 10
Franksville, WI 53126
PMA NumberP050052
Supplement NumberS004
Date Received05/18/2007
Decision Date04/21/2008
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A MODIFIED PRODUCT THAT CONTAINS PHOSPHATE BUFFER SOLUTION, HAS A LOWER EXTRUSION FORCE THAN THE ORIGINAL RADIESSE PRODUCT, AND IS MANUFACTURED USING A ONE-STEP PROCESS.
Post-Approval StudyShow Report Schedule and Study Progress
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