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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 Spiroflex Thrombectomy Set, AngioJet Spiroflex VG Thrombectomy Set
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantBoston Scientific Corp.
One Scimed Place
Maple Grove, MN 55311-1566
PMA NumberP980037
Supplement NumberS090
Date Received06/29/2023
Decision Date08/08/2023
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 for an additional manufacturing site located in Dorado, PR for the Sprioflex and Spiroflex VG Thrombectomy Sets manufacturing, sterile packaging, and post production quality assurance.
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