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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 DERMAL FILLER
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant, dermal, for aesthetic use
Applicant
MERZ NORTH AMERICA, INC
4133 courtney road
suite 10
franksville, WI 53126
PMA NumberP050052
Supplement NumberS045
Date Received10/17/2013
Decision Date03/07/2014
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type135 review track for 30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE QUALIFICATION OF AN AUTOCLAVE.
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