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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 NameDERMAL FILLER PRODUCT HYDRELLE (ELEVESS)
Classification Nameimplant, dermal, for aesthetic use
ApplicantANIKA THERAPEUTICS, INC.
PMA NumberP050033
Supplement NumberS013
Date Received06/20/2011
Decision Date03/09/2012
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
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 updates to the approved product label based on the results of your post-approval clinical study.
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