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. |
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Device | ANCURE(R) ENDOGRAFT(R) SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Boston Scientific Corp. 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P990017 |
Supplement Number | S020 |
Date Received | 05/15/2001 |
Decision Date | 08/17/2001 |
Withdrawal Date
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09/19/2011 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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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