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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.
 
DeviceSPRINTER OVER-THE-WIRE (OTW) BALLOON DILATATION CATHETER (MULTIPLE MODEL NUMBERS FOR THE 1.5 MM TO 4.0 MM DIAMETERS)
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantMedtronic, Ireland
Parkmore Business Park W.
Galway 
PMA NumberP790017
Supplement NumberS081
Date Received12/26/2003
Decision Date06/23/2004
Reclassified Date10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR MINOR DESIGN, PACKAGING AND LABELING CHANGES TO THE STORMER OTW BALLON DILATATION CATHETER INCLUDING THE ADDITION OF 6 MM AND 12 MM BALLOON LENGTHS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPRINTER OTW BALLOON DILATATION CATHETER AND IS INDICATED AS FOLLOWS: FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. THE SPRINTER OTW BALLOON DILATATION CATHETER (BALLOON MODELS 2.5 MM - 4.0 MM) IS ALSO INDICATED FOR POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS. NOTE: BENCH TESTING WAS CONDUCTED WITH THE SPRINTER OTW BALLOON DILATATION CATHETER AND MARKETED BALLOON EXPANDABLE STENTS. CONSIDERATION SHOULD BE TAKEN WHEN THIS DEVICE IS USED WITH DIFFERENT MANUFACTURERS' STENTS DUE TO DIFFERENCES IN STENT DESIGN.
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