| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | BARD E-LUMINEXX VASCULAR STENT |
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| Generic Name | STENT, ILIAC |
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| Applicant | BARD PERIPHERAL VASCULAR, INC.
1415 WEST 3RD ST.
TEMPE, AZ 85281 |
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| PMA Number | P080007 |
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| Date Received | 03/21/2008 |
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| Decision Date | 12/04/2008 |
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| Product Code |
NIO |
| Docket Number | 08M-0645 |
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| Notice Date | 12/19/2008 |
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| Advisory Committee |
Cardiovascular |
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| Clinical Trials | NCT00561457
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
APPROVAL FOR THE BARD E.LUMINEXX VASULAR STENT. THE DEVICE IS INDICATED FOR THE TREATMENT F ILIAC OCCLUSIVE DISEASE IN PATIENTS WITH SYMPTOMATIC VASCULAR DISEASE OF THE COMMON AND/OR EXTERNAL ILIAC ARTERIES UP TO 126 MM IN LENGTH, WITH A REFERENCE VESSEL DIAMETER OF 5 TO 9 MM. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Supplements: |
S001 S003 S004 S005 S007 S008 S009 S010 S011 S013 S014
S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026
S027 |
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