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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.
 
DeviceACX RX COMET VP CORONARY DILATATION CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantAdvanced Cardiovascular Systems, Inc.
26531 Ynez Rd.
Temecula, CA 92591
PMA NumberP810046
Supplement NumberS169
Date Received10/07/1996
Decision Date02/04/1997
Reclassified Date10/08/2010
Product Code LOX 
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 ACS RX COMET VP(TM) CORONARY DILATATION CATHETER. THIS DEVICE IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PROTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR HTE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
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