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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 NamePOSIS ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM
Classification Namecatheter, coronary, atherectomy
Generic Namecatheter
ApplicantPOSSIS MEDICAL, INC.
PMA NumberP980037
Supplement NumberS020
Date Received09/29/2006
Decision Date03/28/2007
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 spiroflex vg catheter the device, as modified, will be marketed under the trade name the angiojet rheolytic thrombectomy system: spiroflex vg rapid exchange rheolytic thrombectomy catheter and is indicated for removing thrombus in the treatment of patients with symptomatic coronary artery or saphenous vein graft lesions in vessels >= 3 mm in diameter prior to balloon angioplasty or stent placement.
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