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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 NameELEVESS
Classification Nameimplant, dermal, for aesthetic use
ApplicantANIKA THERAPEUTICS, INC.
PMA NumberP050033
Supplement NumberS005
Date Received09/19/2007
Decision Date10/03/2007
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the change in product trade name. The device, as modified, will be marketed under the trade name elevess and is indicated for injection into the mid to deep dermis for the correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
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