|
Device | SPRINTER MX2 BALLOON DILATATION CATHETER |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P790017 |
Supplement Number | S083 |
Date Received | 12/10/2004 |
Decision Date | 06/22/2005 |
Reclassified Date
|
10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR ADDING A NEW CATHETER TO THE APPROVED PRODUCT LINE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPRINTER MX2 AND IS INDICATED FOR BALLOON DILATATION FOR THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. THE BALLOON DILATATION CATHETER (BALLOON MODELS 2.5 MM ? 4.0 MM) IS ALSO INDICATED FOR THE POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS. NOTE: BENCH TESTING WAS CONDUCTED WITH THE SPRINTER BALLOON DILATATION CATHETER AND MARKETED BALLOON EXPANDABLE STENTS. CONSIDERATION SHOULD BE TAKEN WHEN THIS DEVICE IS USED WITH DIFFERENT MANUFACTURERS? STENTS DUE TO DIFFERENCES I STENT DESIGN. |