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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.
 
DeviceANGIOJET ULTRA XMI THROMBECTOMY SET, SPIROFLEX, SPIROFLEX VG, DISTAFLEX THROMOBECTOMY SET
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP980037
Supplement NumberS051
Date Received11/05/2015
Decision Date12/02/2015
Product Code MCX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
TO ESTABLISH AN ALTERNATE VENDOR, BOSTON SCIENTIFIC CORPORATION MAPLE GROVE, FOR THE PUMP SUB-ASSEMBLY COMPONENT OF THE ANGIOJET ULTRA THROMBECTOMY SYSTEM.
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