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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.
 
DeviceR1S RAPID EXCHANGE PRE-DILATATION PTCA BALLOON CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantMedtronic, Ireland
Parkmore Business Park W.
Galway 
PMA NumberP790017
Supplement NumberS071
Date Received03/01/2000
Decision Date08/28/2000
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 THE R1S RAPID EXCHANGE BALLOON DILATATION CATHETER. THE DEVICE IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. THE R1S RAPID EXCHANGE BALLOON DILATATION CATHETER IS NOT INTENDED FOR USE AS A PTCA PERFUSION CATHETER BEYOND 60 SECONDS OF BALLOON INFLATION.
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