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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHYDRELLE
Generic NameImplant, dermal, for aesthetic use
ApplicantAnika Therapeutics, Inc.
32 Wiggins Ave.
Beford, MA 01730
PMA NumberP050033
Supplement NumberS017
Date Received05/01/2014
Decision Date05/22/2014
Withdrawal Date04/24/2023
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
TRANSFER OF RESIDUAL SOLVENT RELEASE TESTING FROM S&N LABORATORIES TO IN-HOUSE TESTING AT ANIKA THERAPEUTICS.
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