PMA P810046S205
- Device
- CROSS-SAIL(TM) AND OPENSAIL(TM) CORONARY DILATATION CATHETERS
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S205
- Product code
- LOX
- Decision date
- 2001-01-24
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR THE REVISION OF THE CROSSSAIL AND OPENSAIL CORONARY DILATATION CATHETER'S COMPLIANCE CHARTS. THESE CATHETERS ARE 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 ARTERY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION.
Current openFDA PMA Record#
- Device
- CROSS-SAIL(TM) AND OPENSAIL(TM) CORONARY DILATATION CATHETERS
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S205
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2001-01-24
- Decision code
- APPR
- Date received
- 2000-12-19
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE REVISION OF THE CROSSSAIL AND OPENSAIL CORONARY DILATATION CATHETER'S COMPLIANCE CHARTS. THESE CATHETERS ARE 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 ARTERY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION.