TALENT THORACIC STENT GRAFT SYSTEM
FDA premarket approval P070007/S016 · decided 2010-04-01
Approval details
- PMA number
- P070007
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TALENT THORACIC STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2010-03-12
- Decision date
- 2010-04-01
- Days to decision
- 20 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR A CHANGE TO THE STENT GRAFT SPRING ATTACHMENT TENSILE STRENGTH SPECIFICATION.
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