|
Device | EPIC SELF-EXPANDING NITINOL STENT SYSTEM |
Generic Name | STENT, ILIAC |
Applicant | Boston Scientific Corp. Ballybrit Industrial Estate, Ballybrit Galway H91 Y |
PMA Number | P110035 |
Date Received | 09/13/2011 |
Decision Date | 04/13/2012 |
Product Code |
NIO |
Docket Number | 12M-0373 |
Notice Date | 04/25/2012 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00896337
|
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE EPIC VASCULAR SELF-EXPANDING STENT SYSTEM. THIS DEVICE IS INDICATED FOR THE IMPROVEMENT OF LUMINAL DIAMETER IN PATIENTS WITH DE NOVO OR RESTENOTIC SYMPTOMATIC ATHEROSCLEROTIC LESIONS UP TO 120 MM IN LENGTH IN THE COMMON AND/OR EXTERNAL ILIAC ARTERIES, WITH A REFERENCE VESSEL DIAMETER BETWEEN 5 AND 11 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 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 S051 S052 S053 S054 S055 S056 S057 S058 S059 S060 S061 S062 S063 S064 S065 S066 S067 S068 S069 S070 S071 S072 |