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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 nasolabial folds
ApplicantMERZ NORTH AMERICA, INC
PMA NumberP050052
Supplement NumberS046
Date Received10/31/2013
Decision Date11/27/2013
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Elimination of a test performed on the radiesse dermal filler.
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