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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.
DeviceRevanesse Lips+ 1.2 mL
Generic Nameimplant, dermal, for aesthetic use
138 industrial parkway north
aurora L4G 4
PMA NumberP160042
Supplement NumberS014
Date Received11/10/2020
Decision Date05/07/2021
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for the increase in syringe volume from 1.0 mL to 1.2 mL of Revanesse Lips+