PMA P810046S230

Device: VOYAGER NC CORONARY DILATATION CATHETER
Applicant: Advanced Cardiovascular Systems, Inc.
PMA number: P810046
Supplement: S230
Product code: MAF
Decision date: 2009-07-15
Classification: Stent, Coronary
Generic name: STENT, CORONARY
Approval order statement: APPROVAL TO MODIFY THE PROTECTIVE BALLOON SHEATH. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VOYAGER NC CORONARY DILATATION CATHETER AND IS INDICATED FOR: 1) BALLOON DILATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION; 2) BALLOON DILATION OF A CORONARY ARTERY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION; AND 3) BALLOON DILATION OF A STENT AFTER IMPLANTATION.

Current openFDA PMA Record#

Device: VOYAGER NC CORONARY DILATATION CATHETER
Applicant: Advanced Cardiovascular Systems, Inc.
PMA number: P810046
Supplement: S230
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 2009-07-15
Decision code: APPR
Date received: 2009-04-01
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO MODIFY THE PROTECTIVE BALLOON SHEATH. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VOYAGER NC CORONARY DILATATION CATHETER AND IS INDICATED FOR: 1) BALLOON DILATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION; 2) BALLOON DILATION OF A CORONARY ARTERY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION; AND 3) BALLOON DILATION OF A STENT AFTER IMPLANTATION.