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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 PHEOLYTIC THROMBECTOMY SYSTEM
Classification Namecatheter, coronary, atherectomy
Generic Namecatheter, coronary, atherectomy
Applicant
Boston Scientific Corp.
9055 evergreen blvd nw
minneapolis, MN 55433
PMA NumberP980037
Supplement NumberS010
Date Received05/19/2004
Decision Date06/22/2004
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the packaging specifically to the inner tray and outer pouch.
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