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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.
 
DeviceEXCLUDER AAA ENDOPROSTHESIS SIM-PULL
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantW.L. GORE & ASSOCIATES,INC
32360 N. North Valley Parkway
Phoenix, AZ 85085
PMA NumberP020004
Supplement NumberS087
Date Received09/09/2013
Decision Date10/08/2013
Product Code MIH 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
DUPLICATION OF THE CURRENT COMBINED SIM-PULL AND C3 CATHETER MANUFACTURING PROCESS; ADDITION OF A NEW ISO 8 CLEANROOM AT AN ALREADY APPROVED FACILITY; AND MACHINERY ANDRECIPES UPGRADES AT BOTH APPROVED MANUFACTURING FACILITIES.
Post-Approval StudyShow Report Schedule and Study Progress
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