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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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 (+) LIDOCAINE DERMAL FILTER
Generic NameImplant, dermal, for aesthetic use
ApplicantMERZ NORTH AMERICA, INC
4133 COURTNEY ROAD
SUITE 10
FRANKSVILLE, WI 53126
PMA NumberP050052
Supplement NumberS052
Date Received04/09/2014
Decision Date01/30/2015
Product Code LMH 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT01069354
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR MODIFICATION TO THE FORMULATION, SYRINGE MATERIAL, SPECIFICATIONS, MANUFACTURING PROCESS AND LABELING TO SUPPORT THE ADDITION OF THE LIDOCAINE AND IMPROVE MANUFACTURING EFFICACY. THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME,RADIESSE® (+) AND IS INDICATED FOR SUB-DERMAL IMPLANTATION THE CORRECTION OF MODERATE TO SEVERE FACIAL FOLDS AND WRINKLES, INCLUDING NASOLABIAL FOLDS.
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