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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)REBEL(TM) PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantScimed Life Systems, Inc.
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP860019
Supplement NumberS118
Date Received09/19/1996
Decision Date04/24/1997
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 A NEW SINGLE-OPERATOR EXCHANGE CATHETER WITH A SELF-CONTAINED CONTRAST DISPLACEMENT SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SCIMED(R) REBEL(TM) PTCQA CATHETHER AND IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PROTION OF A CORONARY ARTYER OR BYPASS GRAT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
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