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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 RHEDOLYTIC THROMBECTOMY SYSTEM CORONARY USE
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantBoston Scientific Corp.
One Scimed Place
Maple Grove, MN 55311-1566
PMA NumberP980037
Supplement NumberS011
Date Received06/16/2004
Decision Date06/30/2004
Product Code MCX 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A BOXED WARNING REGARDING USE IN PULMONARY VASCULATURE TO ALL POSSIS ANGIOJET CATHETER INSTRUCTION FOR USE DOCUMENTS.
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