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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 THROMBECTOMY SYSTEM
Classification Namecatheter, coronary, atherectomy
ApplicantMEDRAD, INC.
PMA NumberP980037
Supplement NumberS039
Date Received11/15/2011
Decision Date01/09/2013
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 a new device, the angiojet ultra system with the distaflex thrombectomy set with a 3 french distal diameter. The device, as modified, will be marketed under the trade name angiojet ultra system with the distaflex thrombectomy set and is indicated for removing thrombus in the treatment of patients with symptomatic coronary artery or svg lesions in vessels ¿ 2. 0 mm in diameter prior to balloon angioplasty or stent placement.
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