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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 Versa
Generic NameImplant, dermal, for aesthetic use
ApplicantPROLLENIUM MEDICAL TECHNOLOGIES INC.
138 INDUSTRIAL PARKWAY NORTH
AURORA L4G 4
PMA NumberP160042
Supplement NumberS007
Date Received09/26/2018
Decision Date07/24/2019
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for 2-year shelf-life of Revanesse Versa.
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