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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 NumberS008
Date Received05/19/2004
Decision Date07/15/2004
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 CHANGES TO ANGIOJET XMI CATHETER WHICH INCLUDED: 1) ADDITION OF A PROXIMAL MARKER BAND; 2) CHANGES TO THE PROXIMAL SHAFT; AND 3) CHANGES TO THE STRAIN RELIEF.
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