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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
ApplicantABBOTT VASCULAR INC.
PMA NumberP890043
Supplement NumberS039
Date Received11/06/2006
Decision Date12/11/2006
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate sterilization site located at sterigenics, santa teresa, new mexico.
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