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Device | ANCURE/AORTOILIAC ENDOGRAFT SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Boston Scientific Corp. 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P990017 |
Supplement Number | S030 |
Date Received | 12/19/2001 |
Decision Date | 04/24/2002 |
Withdrawal Date
|
09/19/2011 |
Product Code |
MIH |
Docket Number | 02M-0298 |
Notice Date | 07/02/2002 |
Advisory Committee |
Cardiovascular |
Supplement Type | Panel Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ANCURE AORTOILIAC SYSTEM. THIS DEVICE IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTO-ILIAC ANEURYSMS IN PATIENTS WHOSE ANATOMY DOES NOT ALLOW THE USE OF A TUBE OR BIFURCATED DEVICE. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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