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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 RHEOLYTIC XMI THROMBECTOMY CATHETER
Classification Namecatheter, coronary, atherectomy
Generic Namecatheter
ApplicantPOSSIS MEDICAL, INC.
PMA NumberP980037
Supplement NumberS004
Date Received01/31/2001
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 the xmi catheter, a modification of the lf140 catheter. The device as modified, will be marketed under the trade name possis angiojet xmi 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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