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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 CATHETER SYSTEM
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantBoston Scientific Corp.
One Scimed Place
Maple Grove, MN 55311-1566
PMA NumberP980037
Supplement NumberS012
Date Received01/07/2005
Decision Date02/04/2005
Product Code MCX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE FOR THE SUPPLY LINE NUT OF THE ANGIOJET PUMP SET.
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