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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 Place
Maple Grove, MN 55311-1566
PMA NumberP980037
Supplement NumberS074
Date Received05/17/2019
Decision Date11/13/2019
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
Approval Order Statement  
Approval to use the Boston Scientific Coventry facility as an alternate sterilization site for AngioJet Ultra Thrombectomy Sets.
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