|
Device | COMPLETE SE VASCULAR STENT SYSTEM |
Generic Name | STENT, ILIAC |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P090006 |
Date Received | 04/15/2009 |
Decision Date | 03/17/2010 |
Withdrawal Date
|
05/23/2019 |
Product Code |
NIO |
Docket Number | 10M-0158 |
Notice Date | 03/26/2010 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00730730
|
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE COMPLETE SE VASCULAR STENT SYSTEM (20-100MM LENGTHS). THE DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH ILIAC STENOSIS IN PREVIOUSLY UNSTENTED LESIONS WITH VESSEL REFERENCE DIAMETERS BETWEEN 4.5MM AND 9.5MM AND LESION LENGTHS UP TO 90MM. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Supplements: |
S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 |