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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 XMI AND XMI-RX CATHETERS
Classification Namecatheter, coronary, atherectomy
Generic Namecatheter
ApplicantPOSSIS MEDICAL, INC.
PMA NumberP980037
Supplement NumberS016
Date Received10/19/2005
Decision Date07/11/2006
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes to the ifu for the angiojet xmi and angiojet xmi-rx catheters for use in the coronary vasculature.
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