VOYAGER OTW CORONARY DILATION CATHETER
FDA premarket approval P810046/S214 · decided 2004-03-12
Approval details
- PMA number
- P810046
- Supplement
- S214
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VOYAGER OTW CORONARY DILATION CATHETER
- Generic name
- CATHETER, FLOW DIRECTED
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 2003-09-15
- Decision date
- 2004-03-12
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- DYG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR A NEW CORONARY DILATATION CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VOYAGER OTW CORONARY DILATATION CATHETER AND 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, 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 A
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