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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceFLEXI-CUT DIRECTIONAL DEBULKING SYSTEM
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantAbbott Vascular
26531 Ynez Rd., Bldg. G, Mailing P.O. 9018
Temecula, CA 92590
PMA NumberP890043
Supplement NumberS035
Date Received03/06/2000
Decision Date04/06/2001
Withdrawal Date09/05/2014
Product Code MCX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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