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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
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP980037
Supplement NumberS014
Date Received08/01/2005
Decision Date12/07/2006
Product Code MCX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A REDESIGN OF THE DRIVE UNIT (ULTRA CONSOLE) AND TO COMBINE THE PUMP SET AND CATHETERS INTO A SINGLE THROMBECTOMY SET (WITH DIFFERENT MODELS CORRESPONDING TO THE CURRENT XMI AND XMI-RX CATHETER MODELS).
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