|
Device | SPRINTER LEGEND RX 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 | S096 |
Date Received | 03/31/2008 |
Decision Date | 10/31/2008 |
Reclassified Date
|
10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE SPRINTER LEGEND RAPID EXCHANGE BALLOON DILATATION CATHETER. THE DEVICE, AS MODIFIED, 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 BALLOON DILATATION CATHETER (BALLOON MODELS 2.25 MM ¿ 4.0 MM) IS ALSO INDICATED FOR POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS. |