PMA P810046S214

Device: VOYAGER OTW CORONARY DILATION CATHETER
Applicant: Advanced Cardiovascular Systems, Inc.
PMA number: P810046
Supplement: S214
Product code: DYG
Decision date: 2004-03-12
Generic name: CATHETER, FLOW DIRECTED
Approval order statement: APPROVAL FOR A NEW CORONARY DILATATION CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VOYAGER OTW CORONARY DILATATION CATHETER AND IS INDICATED FOR 1) BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION, 2) BALLOON DILATATION OF A CORONARY ARTERY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION, 3) BALLOON DILATATION OF A STENT AFTER IMPLANTATION.

Current openFDA PMA Record#

Device: VOYAGER OTW CORONARY DILATION CATHETER
Applicant: Advanced Cardiovascular Systems, Inc.
PMA number: P810046
Supplement: S214
Product code: DYG
Generic name: CATHETER, FLOW DIRECTED
Decision date: 2004-03-12
Decision code: APPR
Date received: 2003-09-15
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A NEW CORONARY DILATATION CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VOYAGER OTW CORONARY DILATATION CATHETER AND IS INDICATED FOR 1) BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION, 2) BALLOON DILATATION OF A CORONARY ARTERY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION, 3) BALLOON DILATATION OF A STENT AFTER IMPLANTATION.