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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 Rheolytic Thrombectomy System
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP980037
Supplement NumberS065
Date Received04/17/2017
Decision Date06/02/2017
Product Code MCX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at BSC Maple Grove, Two Scimed Place Maple Grove, Minnesota for final sterilization packaging and labeling.
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