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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 THROMBECTOMY SYSTEM CONSOLE
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP980037
Supplement NumberS045
Date Received12/24/2014
Decision Date03/31/2015
Product Code MCX 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF AN INRUSH CURRENT LIMITER TO THE ANGIOJET ULTRA CONSOLE.
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