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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 1.0 mL, Revanesse Versa 1.2 mL, Revanesse Versa + with Lidocaine 1.0 mL, Revanesse Versa + with Lidocain
Generic NameImplant, dermal, for aesthetic use
ApplicantProllenium Medical Technologies, Inc.
138 Industrial Pkwy. N.
Aurora L4G 4C3
PMA NumberP160042
Supplement NumberS019
Date Received05/02/2022
Decision Date03/01/2024
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of a secondary manufacturing site and a sterilizer for the design, manufacturing and sterilization of Revanesse Versa, Revanesse Versa+ with lidocaine and Revanesse Lips+ with lidocaine in 1.0 mL and 1.2 mL configuration.
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