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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 NameHYDRELLE
Classification Nameimplant, dermal, for aesthetic use
ApplicantANIKA THERAPEUTICS, INC.
PMA NumberP050033
Supplement NumberS009
Date Received08/04/2010
Decision Date08/25/2010
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type Special Supplement
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a quality control test method change for protein content determination of sodium hyaluronate (naha) powder from the current internal modified lowry test method (tms-219) to the modified lowry test method in the european pharmacopoeia (ep) sodium hyaluronate monograph.
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