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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- 1.5CC, 8071M0, RADIESSE INJECTABLE IMPLANT-0.8CC, 8069M0, RADIESSE INJECTABLE IMPLANT-0.3CC
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 NumberS037
Date Received09/20/2012
Decision Date10/17/2012
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 
Addition of defect categories to the incoming inspection procedures based on risk and commensurate with severity.
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