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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(R) ENDOGRAFT(R) SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantBoston Scientific Corp.
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP990017
Supplement NumberS020
Date Received05/15/2001
Decision Date08/17/2001
Withdrawal Date 09/19/2011
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES TO MANUFACTURING PROCESS (ADDITION OF NEW IN-PROCESS QUALITY CHECKS, QUANTIFICATION OF INSPECTION CRITERIA, REMOVAL OF REDUNDANT WIRE INSPECTION, DEFINITION OF TESTING REQUIREMENTS FOR NEW LOTS OF ELGILOY WIRE, DIMENSIONAL CHANGES, AND ADDITION OF REQUIREMENTS FOR CONDUCTING CORROSION FATIGUE TESTING).
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