• 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 has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceRestylane Refyne, Restylane Defyne
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant, dermal, for aesthetic use
Applicant
Q-Med AB
seminariegatan 21
uppsala S-752-7522
PMA NumberP140029
Date Received12/11/2014
Decision Date12/09/2016
Product Code
LMH[ Registered Establishments with LMH ]
Docket Number 16M-4344
Notice Date 12/14/2016
Advisory Committee General & Plastic Surgery
Clinical Trials NCT01205048
NCT01205061
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for Restylane Refyne is indicated for injection into the mid-to-deep dermis for the correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in patients over the age of 21. Restylane Defyne is indicated for injection into the mid-to-deep dermis for the correction of moderate to severe, deep facial wrinkles and folds (such as nasolabial folds) in patients over the age of 21.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements: S001 S003 S004 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 
-
-