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 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.
 
DeviceASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM
Generic NameSTENT, ILIAC
ApplicantMEDTRONIC IRELAND
Parkmore Business Park West
Galway 
PMA NumberP110011
Date Received04/01/2011
Decision Date10/26/2011
Withdrawal Date 01/22/2020
Product Code NIO 
Docket Number 11M-0791
Notice Date 11/04/2011
Advisory Committee Cardiovascular
Clinical TrialsNCT00753337
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING ILIAC LUMINAL DIAMETER IN PATIENTS WITH DE NOVO AND RESTENOTIC LESIONS IN THE COMMON AND EXTERNAL ILIAC ARTERIES, WITH REFERENCE VESSEL DIAMETERS BETWEEN 6 MM AND 10 MM AND LESION LENGTHS UP TO 61 MM. THE STENT IS INTENDED AS A PERMANENT IMPLANT.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S012 
S013 
-
-