TALENT THORACIC STENT GRAFT WITH XCELERANT DELIVERY SYSTEM
FDA premarket approval P070007/S001 · decided 2008-06-27
Approval details
- PMA number
- P070007
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TALENT THORACIC STENT GRAFT WITH XCELERANT DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2008-06-09
- Decision date
- 2008-06-27
- Days to decision
- 18 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR USE OF THE NEW XCELERANT DELIVERY SYSTEM WITH THE TALENT THORACIC STENT GRAFT.
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