POWERSAIL(TM)/HIGHSAIL(TM) CORONARY DILATATION CATHETER
FDA premarket approval P810046/S204 · decided 2001-03-02
Approval details
- PMA number
- P810046
- Supplement
- S204
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- POWERSAIL(TM)/HIGHSAIL(TM) CORONARY DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 2000-10-20
- Decision date
- 2001-03-02
- Days to decision
- 133 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- 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 DILATAT
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