RX CHASSIS 3 CORONARY DILATATION CATHETER
FDA premarket approval P810046/S215 · decided 2004-07-16
Approval details
- PMA number
- P810046
- Supplement
- S215
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RX CHASSIS 3 CORONARY DILATATION CATHETER
- Generic name
- CATHETER, FLOW DIRECTED
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 2004-01-26
- Decision date
- 2004-07-16
- Days to decision
- 172 days
- Decision code
- APPR
- Product code
- DYG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR THE RX CHASSIS 3 CORONARY DILATION CATHETER. THE DEVICE, AS MODIFIED, 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, AND 2) BALLOON DILATATION OF A CORONARY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION.
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