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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.
 
DevicePOWERSAIL(TM)/HIGHSAIL(TM) CORONARY DILATATION CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
ApplicantADVANCED CARDIOVASCULAR SYSTEMS, INC.
26531 YNEZ RD.
TEMECULA, CA 92591
PMA NumberP810046
Supplement NumberS204
Date Received10/20/2000
Decision Date03/02/2001
Reclassified Date 10/08/2010
Product Codes DYG LOX 
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 NEW CATHETER MODELS. THE DEVICES, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES POWERSAIL(TM) AND HIGHSAIL(TM) CORONARY DILATATION CATHETERS AND ARE INDICATED FOR: 1) BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. 2) BALLOON DILATATION OF A CORONARY ARTERY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION. 3) BALLOON DILATATION OF THE ACS MULTI-LINK(TM), ACS MULTI-LINK(TM), ACS MULTI-LINK DUET(TM), ACS MULTI-LINK TRISTAR(TM), MULTI-LINK TETRA(TM) OR ACS MULTI-LINK ULTRA(TM) STENTS AFTER IMPLANTATION.
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