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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 NumberS037
Date Received06/07/2001
Decision Date12/05/2001
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes for the flexi-cut(tm) directional debulking system. The labeling changes include the addition of a summary of the physician preference testing information, and the addition of a warning statement to remove atheromatous tissue from the nosecone frequently to avoid guidewire restriction.
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