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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceRADIESSE
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 NumberS054
Date Received05/23/2014
Decision Date06/19/2014
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to the assembly process for the syringes used with the radiesse dermal filler.
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