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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.
 
DeviceR2L RAPID EXCHANGE BALLOON DILATATION CATHETER WITH EXTENDED PRESSURE RANGE AND D2L OVER-THE-WIRE BALLOON DILATATION CAT
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantMEDTRONIC IRELAND
Parkmore Business Park West
Galway 
PMA NumberP790017
Supplement NumberS075
Date Received03/29/2001
Decision Date06/01/2001
Reclassified Date 10/08/2010
Product Code 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 THE R2L RAPID EXCHANGE AND D2L OVER-THE-WIRE BALLOON DILATATION CATHETERS WITH EXTENDED PRESSURE RANGE. THE DEVICES ARE INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
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