|
Device | ANCURE TUBE AND BIFURCATED 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 | S010 |
Date Received | 09/25/2000 |
Decision Date | 11/21/2000 |
Withdrawal Date
|
09/19/2011 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF A COATING TO THE INFERIOR (TUBE ONLY) AND SUPERIOR CAPSULES (ALL CONFIGURATIONS) OF THE ANCURE(R) DELIVERY CATHETERS. |