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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceANCURE TUBE AND BIFURCATED ENDOGRAFT SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantBoston Scientific Corp
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP990017
Supplement NumberS010
Date Received09/25/2000
Decision Date11/21/2000
Withdrawal Date09/19/2011
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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