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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceANGIOJET RHEDOLYTIC THROMBECTOMY SYSTEM CORONARY USE
Classification Namecatheter, coronary, atherectomy
Generic Namecatheter, coronary, atherectomy
Applicant
Boston Scientific Corp.
9055 evergreen blvd nw
minneapolis, MN 55433
PMA NumberP980037
Supplement NumberS011
Date Received06/16/2004
Decision Date06/30/2004
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Expedited Review Granted? No
Combination Product No
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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