PMA - Premarket Approval

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New Search Back to Search Results Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.   Trade Name ELEVESS Classification Name implant, dermal, for aesthetic use Applicant ANIKA THERAPEUTICS, INC. PMA Number P050033 Date Received 09/02/2005 Decision Date 12/20/2006 Product Code LMH [ Registered Establishments with LMH ] Docket Number 06M-0531 Notice Date 12/26/2006 Advisory Committee General & Plastic Surgery Expedited Review Granted? No Information About: Labeling, Approval Order, Summary of Safety and Effectiveness Approval Order Statement  Approval for the cosmetic tissue augmentation product. This device is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). Post-Approval Study Show Report Schedule and Study Progress Supplements: S001 S002 S003 S004 S005 S007