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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 NumberS037
Date Received06/07/2001
Decision Date12/05/2001
Withdrawal Date09/05/2014
Product Code MCX 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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