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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(R) SURPASS(TM) PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantSCIMED LIFE SYSTEMS, INC.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP860019
Supplement NumberS111
Date Received04/16/1996
Decision Date07/01/1996
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 THE SCIMED SURPASS PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PERFUSION CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED FOR THE BALLOON DILATATION OF THE STENOTIC PORTIO OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION
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