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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 SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantBoston Scientific Corp.
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP990017
Supplement NumberS038
Date Received02/10/2003
Decision Date08/08/2003
Withdrawal Date 09/19/2011
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE FORMAT TO BE USED FOR THE CLINICAL UPDATE THAT WILL BE PROVIDED TO PHYSICIANS USERS AT LEAST ANNUALLY. THE INFORMATION CONTAINED IN THIS UPDATE WILL BE PROVIDED TO THE FDA VIA THE PMA ANNUAL REPORT.
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