PMA P810046S215

Device: RX CHASSIS 3 CORONARY DILATATION CATHETER
Applicant: Advanced Cardiovascular Systems, Inc.
PMA number: P810046
Supplement: S215
Product code: DYG
Decision date: 2004-07-16
Classification: Catheter, Flow Directed
Generic name: CATHETER, FLOW DIRECTED
Approval order statement: APPROVAL FOR THE RX CHASSIS 3 CORONARY DILATION 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, AND 2) BALLOON DILATATION OF A CORONARY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION.

Current openFDA PMA Record#

Device: RX CHASSIS 3 CORONARY DILATATION CATHETER
Applicant: Advanced Cardiovascular Systems, Inc.
PMA number: P810046
Supplement: S215
Product code: DYG
Generic name: CATHETER, FLOW DIRECTED
Decision date: 2004-07-16
Decision code: APPR
Date received: 2004-01-26
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE RX CHASSIS 3 CORONARY DILATION 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, AND 2) BALLOON DILATATION OF A CORONARY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION.