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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 0.8 CC, 8069M0, RADIESSE INJECTABLE IMPLANT- 0.3C
Classification Nameimplant, dermal, for aesthetic use
Generic Nameinjectable calcium hydroxylapatite implant for soft tissue augmentation for the treatment of facial lipoatrophy
ApplicantMERZ AESTHETICS, INC.
PMA NumberP050037
Supplement NumberS034
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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