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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.
 
DeviceHYDRELLE
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant, dermal, for aesthetic use
Applicant
Anika Therapeutics, Inc.
32 wiggins avenue
bedford, MA 01730
PMA NumberP050033
Supplement NumberS017
Date Received05/01/2014
Decision Date05/22/2014
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Transfer of residual solvent release testing from s&n laboratories to in-house testing at anika therapeutics.
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