THE ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM
FDA premarket approval P990020/S009 · decided 2002-11-21
Approval details
- PMA number
- P990020
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THE ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2002-06-03
- Decision date
- 2002-11-21
- Days to decision
- 171 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR THE XPEDIENT DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANEURX STENT GRAFT WITH EXPEDIENT DELIVERY SYSTEM AND IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTO-ILIAC ANEURYSMS HAVING: 1) INFRARENAL, NON-ANEURYSMAL, NECK LENGTH OF GREATER THAN 1 CM AT THE PROXIMAL AND DISTAL ENDS OF THE ANEURYSM AND AN INNER VESSEL DIAMETER APPROXIMATELY 10-20% SMALLER THAN THE LABELED DEVICE DIAMETER: 2) MORPHOLOGY SUITABLE FOR E
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