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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 NumberS009
Date Received08/04/2010
Decision Date08/25/2010
Withdrawal Date04/24/2023
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
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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