|
Device | MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW) |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | ABBOTT VASCULAR DEVICES 400 SAGINAW DR. REDWOOD CITY, CA 94063 |
PMA Number | P910031 |
Supplement Number | S023 |
Date Received | 11/16/2004 |
Decision Date | 02/16/2006 |
Reclassified Date
|
10/08/2011 |
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 MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW). THE MERLIN PTCA CATHETER (OTW) IS INDICATED FOR USE IN BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. THE NC MERLIN PTCA CATHETER (OTW) IS INDICATED FOR USE IN BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION, AND FOR THE POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS. |