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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 INJECTABLE IMPLANT
Classification Nameimplant, dermal, for aesthetic use
Generic Nameinjectable calcium hydroxylapatite implant for soft tissue augmentation for the treatment of nasolabial folds
ApplicantMERZ AESTHETICS, INC.
PMA NumberP050052
Supplement NumberS035
Date Received03/06/2012
Decision Date11/08/2012
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 a change to syringe assembly.
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