PMA P810046S216

Device: VOYAGER RX CORONARY DILATATION CATHETER
Applicant: Advanced Cardiovascular Systems, Inc.
PMA number: P810046
Supplement: S216
Product code: LOX
Decision date: 2004-06-18
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: APPROVAL FOR THE VOYAGER RX CORONARY DILATATION CATHETER. THE DEVICE, AS MODIFIED, 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 OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION, AND 3) BALLOON DILATATION OF STENT AFTER IMPLANTATION (TESTING INCLUDING THE FOLLOWING GUIDANT STENTS: MULTI-LINK: PIXEL AND PENTA AND ZETA CORONARY STENT SYSTEMS).

Current openFDA PMA Record#

Device: VOYAGER RX CORONARY DILATATION CATHETER
Applicant: Advanced Cardiovascular Systems, Inc.
PMA number: P810046
Supplement: S216
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 2004-06-18
Decision code: APPR
Date received: 2004-03-08
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE VOYAGER RX CORONARY DILATATION CATHETER. THE DEVICE, AS MODIFIED, 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 OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION, AND 3) BALLOON DILATATION OF STENT AFTER IMPLANTATION (TESTING INCLUDING THE FOLLOWING GUIDANT STENTS: MULTI-LINK: PIXEL AND PENTA AND ZETA CORONARY STENT SYSTEMS).