|
Device | R1S RAPID EXCHANGE PRE-DILATATION PTCA BALLOON 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 | S071 |
Date Received | 03/01/2000 |
Decision Date | 08/28/2000 |
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 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. |