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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.
Classification Nameimplant, dermal, for aesthetic use
Generic Nameinjectable poly-l-lactic acid
PMA NumberP030050
Supplement NumberS017
Date Received04/05/2013
Decision Date10/10/2014
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Clinical Trials NCT00360932
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in product labeling to describe the results of a post approval study in patients with hiv associated lipoatrophy.