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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 NumberS022
Date Received05/09/2023
Decision Date06/06/2023
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for revisions to the clinician labeling and patient labeling as a result of postmarket surveillance data.
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