PMA P810046S203
- Device
- RX CHASSIS I CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S203
- Product code
- LOX
- Decision date
- 2001-01-11
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR THE RX CHASSIS 1(TM) CORONARY DILATATION CATHETER. THE DEVICE, AS MODIFIED, IS INDICATED FOR A) BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OF BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION, AND B) BALLOON DILATATION OF A CORONARY ARTERY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST SEGMENT ELEVATION MYOCARDIAL INFARCTION.
Current openFDA PMA Record#
- Device
- RX CHASSIS I CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S203
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2001-01-11
- Decision code
- APPR
- Date received
- 2000-10-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE RX CHASSIS 1(TM) CORONARY DILATATION CATHETER. THE DEVICE, AS MODIFIED, IS INDICATED FOR A) BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OF BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION, AND B) BALLOON DILATATION OF A CORONARY ARTERY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST SEGMENT ELEVATION MYOCARDIAL INFARCTION.