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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 facial lipoatrophy
ApplicantMERZ AESTHETICS, INC.
PMA NumberP050037
Supplement NumberS028
Date Received03/30/2011
Decision Date06/20/2012
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of safety and effectiveness clinical data and post-marketing surveillance data from the post approval studies performed as a condition of approval for the radiesse injectable implant. The device, as modified, will be marketed under the trade name radiesse injectable implant and is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.
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