ANEURX AAADVANTAGE STENT GRAFT WITH XCELERANT DELIVERY SYSTEM
FDA premarket approval P990020/S020 · decided 2006-03-17
Approval details
- PMA number
- P990020
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ANEURX AAADVANTAGE STENT GRAFT WITH XCELERANT DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2005-06-24
- Decision date
- 2006-03-17
- Days to decision
- 266 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR ADDITIONAL ILIAC SIZES (INCLUDING 18MM AND 20MM DIAMETERS; FLARED ILIAC AND ILIAC CUFFS IN 16 MM X 20MM, 18MM X 22MM, AND 18MM X 24MM); A LONGER AORTIC BODY OF THE BIFURCATED COMPONENT BY 1 CM; PRE-SHAPED (CONTOURED) STENT RINGS; AND PLATINUM-IRIDIUM RADIOPAQUE MARKETS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANEURX AAADVANTAGE STENT GRAFT WITH XCELERANT DELIVERY SYSTEM AND IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTO-ILI
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