RX CHASSIS I CORONARY DILATATION CATHETER
FDA premarket approval P810046/S203 · decided 2001-01-11
Approval details
- PMA number
- P810046
- Supplement
- S203
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RX CHASSIS I CORONARY DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 2000-10-17
- Decision date
- 2001-01-11
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR THE RX CHASSIS 1(TM) CORONARY DILATATION CATHETER. THE DEVICE, AS MODIFIED, IS INDICATED FOR A) BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OF BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION, AND B) BALLOON DILATATION OF A CORONARY ARTERY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST SEGMENT ELEVATION MYOCARDIAL INFARCTION.
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