TALENT ABDOMINAL STENT GRAFT SYSTEM
FDA premarket approval P070027/S011 · decided 2010-02-04
Approval details
- PMA number
- P070027
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TALENT ABDOMINAL STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2009-08-10
- Decision date
- 2010-02-04
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR ADDING THE TALENT CONVERTER STENT GRAFT AND TALENT OCCLUDER ASLINE EXTENSIONS TO THE ALREADY EXISTING TALENT ABDOMINAL PRODUCT FAMILY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TALENT CONVERTER STENT GRAFT SYSTEM WITHXCELERANT HYDRO DELIVERY SYSTEM & TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM. THE TALENT CONVERTER IS INDICATED FOR SECONDARY ENDOVASCULAR INTERVENTION IN PATIENTS HAVING RECEIVED PRIOR ENDOVASCULAR REPAIR OF INFRARENAL ABDOMINAL AORTIC OR AORTOI
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