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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 SYSTEN
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantBoston Scientific Corp.
One Scimed Place
Maple Grove, MN 55311-1566
PMA NumberP980037
Supplement NumberS024
Date Received12/20/2007
Decision Date06/17/2008
Product Code MCX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATIVE HYDROPHILIC COATING MATERIAL AND SUPPLIER (DSM BIOMEDICAL, GLEEN, NETHERLANDS) USED ON THE DISTAL SHAFT OF THE SPIROFLEX FAMILY OF CATHETERS (SPIROFLEX AND SPRIOFLEX VG) AND APPROVAL TO PERFORM THE MANUFACTURING COATING PROCESS OF THE NEW DSM HYDROPHILIC COATING AT THE POSSIS FACILITY, MINNEAPOLIS, MINNESOTA.
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