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Device | ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM |
Generic Name | STENT, ILIAC |
Applicant | ABBOTT VASCULAR INC. 3200 LAKESIDE DRIVE SANTA CLARA, CA 92054 |
PMA Number | P110028 |
Date Received | 07/25/2011 |
Decision Date | 02/22/2012 |
Product Code |
NIO |
Docket Number | 12M-0181 |
Notice Date | 02/27/2012 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00844532
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Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM. THE DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH DE NOVO OR RESTENOTIC ATHEROSCLEROTIC LESIONS IN THE NATIVE COMMON ILIAC ARTERY AND NATIVE EXTERNAL ILIAC ARTERY WITH REFERENCE VESSEL DIAMETERS BETWEEN 4.3 MM AND 9.1 MM AND LESIONS LENGTHS UP TO 90 MM. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023
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