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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 INJECTABLE IMPLANT
Generic NameImplant, dermal, for aesthetic use
ApplicantMerz North America, Inc.
4133 Ct.ney Rd., Suite 10
Franksville, WI 53126
PMA NumberP050052
Supplement NumberS019
Date Received01/14/2009
Decision Date07/13/2009
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
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE TO PROVIDE DETAILED INSTRUCTIONS FOR MIXING RADIESSE WITH 2% LIDOCAINE HCL (RESULTING IN A FINAL CONCENTRATION OF 0.3% LIDOCAINE) PRIOR TO INJECTION FOR THE INDICATED USE OF SUBDERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS, SUCH AS NASOLABIAL FOLDS. THE MIXING OF RADIESSE AND LIDOCAINE IS TO BE ACCOMPLISHED USING A MIXING KIT THAT WILL BE MADE AVAILABLE SEPARATE FROM THE RADIESSE DEVICE.
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