|
Device | RAPTORAIL PTCA DILATATION CATHETER |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. MIAMI LAKES, FL 33014-5700 |
PMA Number | P880003 |
Supplement Number | S082 |
Date Received | 04/02/2001 |
Decision Date | 09/27/2001 |
Reclassified Date
|
10/08/2010 |
Product Codes |
LIT 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 A NEW CATHETER MODEL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RAPTORAIL(TM) PTCA DILATATION CATHETER AND IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. |