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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.
 
DeviceVOYAGER NC CORONARY DILATATION CATHETER
Generic NameSTENT, CORONARY
ApplicantADVANCED CARDIOVASCULAR SYSTEMS, INC.
26531 YNEZ RD.
TEMECULA, CA 92591
PMA NumberP810046
Supplement NumberS232
Date Received12/09/2009
Decision Date02/04/2010
Reclassified Date 10/08/2010
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A LINE EXTENSION FOR A 1.5MM DIAMETER SIZE OF THE VOYAGER NC CORONARY DILATION CATHETER.
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