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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 RHEOLOYTIC THROMBECTOMY SYSTEM
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP980037
Supplement NumberS040
Date Received08/15/2012
Decision Date10/16/2012
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 CHANGING THE PACKAGING TRAY MATERIAL FOR THE ANGIOJET ULTRA XMI, ULTRA SPIROFLEX, AND ULTRA SPIROFLEX VG THROMBECTOMY SETS FROM PETG TO PETG DENEST, AS WELL AS CHANGING THE MANUFACTURING OF THESE PACKAGING TRAYS FROM PERFECSEAL TO BROOKDALE.
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