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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.
 
Trade NameANGIOJET(R) RHEOLYTIC THROMBECTOMY SYSTEM DRIVE UNIT
Classification Namecatheter, coronary, atherectomy
Generic Namedrive unit
ApplicantPOSSIS MEDICAL, INC.
PMA NumberP980037
Supplement NumberS003
Date Received12/19/2000
Decision Date11/20/2001
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for replacement of the outflow bubble detector shutdown function on the drive unit 3000a with a visual alarm that is activated when bubbles are detected in the outflow line.
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