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.
 
DeviceJUVEDERM VOLUMA XC
Generic NameImplant, dermal, for aesthetic use
ApplicantAllergan
2525 DUPONT DR.
IRVINE, CA 92612
PMA NumberP110033
Supplement NumberS019
Date Received08/31/2015
Decision Date09/30/2015
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR REVISED LABELING TO INCLUDE FDA¿S SUGGESTED VERBIAGE, VERBATIM, TO ENHANCE THE INFORMATION PROVIDED TO PATIENTS AND PHYSICIANS ABOUT THE RISKS ASSOCIATED WITH VASCULAR INJECTION.
-
-