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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.
 
DeviceD114S OTW BALLOON DILATATION CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantMEDTRONIC IRELAND
Parkmore Business Park West
Galway 
PMA NumberP790017
Supplement NumberS074
Date Received09/14/2000
Decision Date01/08/2001
Reclassified Date 10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF SIX (6) CATALOGUE ITEMS TO THE APPROVED D114S OVER-THE-WIRE BALLOON DILATATION CATHETER PRODUCT LINE. THESE SIX ITEMS CONSIST OF A 10 MM BALLOON LENGTH IN EACH OF THE CURRENT BALLOON DIAMETERS OF 1.5 MM, 2.0 MM, 2.5 MM, 3.0 MM, 3.5 MM, AND 4.0 MM. IN ADDITION, APPROVAL FOR A MINOR DIMENSIONAL CHANGE TO THE 1.5 MM DIAMETER EXTRUDED BALLOON TUBING (0.0135"/0.0205" ID/OD FROM THE CURRENT 0.014"/0.022" ID/OD. 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.
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