Premarket Approval (PMA)

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.

• Device: ELEVESS (AKA COSMETIC TISSUE AUGMENTATION PRODUCT)
• Generic Name: Implant, dermal, for aesthetic use
• Applicant: Anika Therapeutics, Inc.; 32 Wiggins Ave.; Beford, MA 01730
• PMA Number: P050033
• Supplement Number: S002
• Date Received: 05/31/2007
• Decision Date: 04/29/2008
• Withdrawal Date: 04/24/2023
• Product Code: LMH
• Advisory Committee: General & Plastic Surgery
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - OSB
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY.