VOYAGER NC CORONARY DILATATION CATHETER
FDA premarket approval P810046/S230 · decided 2009-07-15
Approval details
- PMA number
- P810046
- Supplement
- S230
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VOYAGER NC CORONARY DILATATION CATHETER
- Generic name
- STENT, CORONARY
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 2009-04-01
- Decision date
- 2009-07-15
- Days to decision
- 105 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL TO MODIFY THE PROTECTIVE BALLOON SHEATH. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VOYAGER NC CORONARY DILATATION CATHETER AND IS INDICATED FOR: 1) BALLOON DILATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION; 2) BALLOON DILATION OF A CORONARY ARTERY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION; AND 3) BALLOON DILATION OF A
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