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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 NumberS011
Date Received01/22/2020
Decision Date04/21/2020
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 ProductYes
Approval Order Statement  
Approval of change of shelf-life from 12 months to 18 months for Revanesse Versa+.
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