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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 ROAD BUILDING G
MAILING P.O. 9018
TEMECULA, CA 92590
PMA NumberP890043
Supplement NumberS038
Date Received12/21/2004
Decision Date01/14/2005
Withdrawal Date 09/05/2014
Product Code MCX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE TO ALLOW STERILE PRODUCT RELEASE BASED ON DEMONSTRATION OF CONFORMITY TO PRE-DEFINED STERILIZATION PARAMETERS (PARAMETRIC RELEASE) RATHER THAN RELEASE BASED ON DEMONSTRATING NO GROWTH OF BIOLOGICAL INDICATORS (CONVENTIONAL RELEASE).
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