• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameRESTYLANE L INJECTABLE GEL
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant,dermal for aesthetic use
ApplicantMEDICIS AESTHETICS, INC.
PMA NumberP040024
Supplement NumberS056
Date Received01/10/2012
Decision Date08/30/2012
Product Code
LMH[ Registered Establishments with LMH ]
Docket Number 12M-0968
Notice Date 09/12/2012
Advisory Committee General & Plastic Surgery
Clinical Trials NCT00797459
NCT00935272
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for restylane l injectable gel. This device is indicated for: 1) mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds; and 2) submucosal implantation for lip augmentation in patients over the age of 21.
Approval Order Approval Order
-
-