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Device | MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P110040 |
Date Received | 12/12/2011 |
Decision Date | 09/19/2013 |
Withdrawal Date
|
05/23/2019 |
Product Code |
NIP |
Docket Number | 13M-1159 |
Notice Date | 09/23/2013 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00814970
|
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM. THIS DEVICE IS INDICATED TO IMPROVE LUMINAL DIAMETER IN SYMPTOMATIC PATIENTS WITH DE NOVO AND/OR RESTENOTIC LESIONS OR OCCLUSIONS OF THE SUPERFICIAL FEMORAL ARTERY (SFA) OR PROXIMAL POPLITEAL ARTERY (PPA) WITH REFERENCE DIAMETERS RANGING FROM 4 MM TO 7 MM AND LESION LENGTHS UP TO 140 MM. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011
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