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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 NameS-15 HYDRELLE
Classification Nameimplant, dermal, for aesthetic use
ApplicantANIKA THERAPEUTICS, INC.
PMA NumberP050033
Supplement NumberS015
Date Received05/14/2012
Decision Date10/22/2012
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the sample preparation procedure for hplc testing.
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