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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 NamePOSSIS ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM
Classification Namecatheter, coronary, atherectomy
Generic Namecatheter
ApplicantPOSSIS MEDICAL, INC.
PMA NumberP980037
Supplement NumberS007
Date Received11/26/2003
Decision Date05/05/2004
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the xmi rapid exchange (xmi-rx) catheter, a modification of the xmi-otw catheter. The device, as modified, will be marketed under the trade name possis angiojet xmi rapid exchange rheolytic thrombectomy system, and is indicated for removing thrombus in the treatment of patients with symptomatic coronary artery or saphenous vein graft lesions in vessels >=2. 0 mm in diameter prior to balloon angioplasty or stent placement.
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