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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.
 
Trade NameRADIESSE DERMAL FILLER
Classification Nameimplant, dermal, for aesthetic use
Generic Nameinjectable calcium hydroxylapatite implant for soft tissue augmentation for the treatment of facial lipoatrophy
ApplicantMERZ NORTH AMERICA, INC
PMA NumberP050037
Supplement NumberS042
Date Received10/24/2013
Decision Date03/07/2014
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type135 review track for 30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the qualification of an autoclave.
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