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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 NameFLEXI-CUT DIRECTIONAL DEBULKING SYSTEM
Classification Namecatheter, coronary, atherectomy
Generic Namecoronary atherectomy catheter
ApplicantGUIDANT CORP.
PMA NumberP890043
Supplement NumberS035
Date Received03/06/2000
Decision Date04/06/2001
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 flexi-cut(tm) direction debulking system. The flexi-cut(tm) direction debulking system is indicated for use in coronary artery disease accessible to dca (directional coronary atherectomy), generally in the proximal or mid-portion of coronary vessels. It can be used alone or in conjunction with other coronary interventional devices. Dca is intended to improve coronary luminal diameter by mechanically shaving and removing atherosclerotic material from the diseased vessel.
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