TALENT THORACIC STENT GRAFT SYSTEM
FDA premarket approval P070007 · decided 2008-06-05
Approval details
- PMA number
- P070007
- Trade name
- TALENT THORACIC STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2007-03-01
- Decision date
- 2008-06-05
- Days to decision
- 462 days
- Decision code
- APWD
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR THE TALENT THORACIC STENT GRAFT SYSTEM. THE DEVICE IS INDICATED FOR THE ENDOVASCULAR REPAIR OF FUSIFORM ANEURYSMS AND SACCULAR ANEURYSMS/ PENETRATING ULCERS OF THE DESCENDING THORACIC AORTA IN PATIENTS HAVING APPROPRIATE ANATOMY, INCLUDING: 1) ILIAC/FEMORAL ACCESS VESSEL MORPHOLOGY THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES, AND/OR ACCESSORIES; 2) NON-ANEURYSMAL AORTIC DIAMETER IN THE RANGE OF 18-42MM; AND 3) NON-ANEURYSMAL AORTIC PROXIMAL AND DISTAL NECK LENGTHS >=
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