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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; Revanesse Versa+ with Lidocaine, Revanesse Versa+ with Lidocaine 1.2 mL, Revanesse® Versa™ 1.2 mL, Reva
Generic NameImplant, dermal, for aesthetic use
ApplicantProllenium Medical Technologies, Inc.
138 Industrial Pkwy. N.
Aurora L4G 4C3
PMA NumberP160042
Supplement NumberS024
Date Received03/07/2024
Decision Date08/20/2024
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process 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 mixer discharger and piston mill for the milling of the subject device gels.
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