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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 ULTRA THROMBECTOMY SYSTEM
Classification Namecatheter, coronary, atherectomy
Generic Namecatheter, coronary, atherectomy
Applicant
Boston Scientific Corp.
9055 evergreen blvd nw
minneapolis, MN 55433
PMA NumberP980037
Supplement NumberS014
Date Received08/01/2005
Decision Date12/07/2006
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a redesign of the drive unit (ultra console) and to combine the pump set and catheters into a single thrombectomy set (with different models corresponding to the current xmi and xmi-rx catheter models).
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