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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 ENDOGRAFT SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantBoston Scientific Corp
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP990017
Supplement NumberS029
Date Received11/29/2001
Decision Date12/11/2001
Withdrawal Date09/19/2011
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR TEMPORARY ADDITION OF A LABEL TO INSPECT THE CONTRALATERAL CUTTER PACKAGED WITH THE ANCURE DEVICE. THE CHANGE WOULD APPLY TO 436 DEVICES MANUFACTURED BETWEEN OCTOBER 12, 2001 AND NOVEMBER 12, 2001.
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