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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 SYSTEMS
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantBoston Scientific Corp
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP990017
Supplement NumberS012
Date Received11/06/2000
Decision Date02/15/2001
Withdrawal Date09/19/2011
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MODIFICATION TO THE TRAINING PROGRAM TO ALLOW LESS THAN 100% CASE SUPPORT AT CENTERS THAT MEET THE ESTABLISHED CRITERIA. THIS CHANGE AFFECTS THE CONDITIONS OF APPROVAL DESCRIBED IN THE ORIGINAL APPROVAL ORDER, DATED SUPTEMBER 28, 1999.
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