THE TALENT ABDOMINAL STENT GRAFT SYSTEM
FDA premarket approval P070027 · decided 2008-04-15
Approval details
- PMA number
- P070027
- Trade name
- THE TALENT ABDOMINAL STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2007-10-18
- Decision date
- 2008-04-15
- Days to decision
- 180 days
- Decision code
- APWD
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR THE TALENT ABDOMINAL STENT GRAFT SYSTEM. THIS DEVICE IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS WITH OR WITHOUT ILIAC INVOLVEMENT HAVING:1) ILIAC/FEMORAL ACCESS VESSEL MORPHOLOGY THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES, AND/OR ACCESSORIES;2) A PROXIMAL AORTIC NECK LENGTH OF >= 10MM; 3) PROXIMAL AORTIC NECK ANGULATION <= 60?; 4) DISTAL ILIAC ARTERY FIXATION LENGTH OF >=15MM;5) AN AORTIC NECK DIAMETER OF 18-32MM AND ILIAC ARTERY DIAME
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