Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 Pkwy. N.
Aurora L4G 4C3
PMA NumberP160042
Supplement NumberS003
Date Received12/20/2017
Decision Date08/02/2018
Product Code LMH 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT02991040
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of lidocaine to the formulation of Revanesse Versa.
-
-