- Device
- POWERSAIL(TM)/HIGHSAIL(TM) CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S204
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2001-03-02
- Decision code
- APPR
- Date received
- 2000-10-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR NEW CATHETER MODELS. THE DEVICES, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES POWERSAIL(TM) AND HIGHSAIL(TM) CORONARY DILATATION CATHETERS AND 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. 2) BALLOON DILATATION OF A CORONARY ARTERY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION. 3) BALLOON DILATATION OF THE ACS MULTI-LINK(TM), ACS MULTI-LINK(TM), ACS MULTI-LINK DUET(TM), ACS MULTI-LINK TRISTAR(TM), MULTI-LINK TETRA(TM) OR ACS MULTI-LINK ULTRA(TM) STENTS AFTER IMPLANTATION.