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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.
 
DeviceSIMPSON CORONARY ATHEROCATH(TM)
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantABBOTT VASCULAR
26531 YNEZ ROAD BUILDING G
MAILING P.O. 9018
TEMECULA, CA 92590
PMA NumberP890043
Supplement NumberS006
Date Received11/09/1990
Decision Date03/19/1991
Withdrawal Date 09/05/2014
Product Code MCX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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