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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.
 
DeviceSCIMED TRANSPORT CORONARY BALLOON DILATATION-INFUSION CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantSCIMED LIFE SYSTEMS, INC.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP860019
Supplement NumberS113
Date Received05/02/1996
Decision Date04/09/1997
Reclassified Date 10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A NEW BALLOON DILATATION AND INFUSION CATHETER. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME SCIMED(R) TRANSPORT(R) CORONARY BALLOON DILATATION-INFUSION CATHETER AND IS INDICATD FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FO RTHE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. THE TRANSPORT(R) CATHETER IS ALSO INTENDED TO INFUSION FLUIDS SUCH AS HEPARINIZED SALINE, AND THROMBOLYTIC AGENTS SUCH AS UROKINASE, INTOT EH VASCULATURE WHEN THE DILATATION BALLOON IS DEFLATED OR INFLATED TO PRESSURES UP TO 3 ATMOSPHERES.
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