|
Device | ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM |
Generic Name | STENT, ILIAC |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P110011 |
Date Received | 04/01/2011 |
Decision Date | 10/26/2011 |
Withdrawal Date
|
01/22/2020 |
Product Code |
NIO |
Docket Number | 11M-0791 |
Notice Date | 11/04/2011 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00753337
|
Expedited Review Granted? | No |
Combination Product | No |
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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Supplements: |
S006 S001 S004 S012 S002 S009 S010 S005 S008 S007 S013 S003 |