PMA P070007S021
- Device
- TALENT THORACIC STENT GRAFT SYSTEM
- Applicant
- Medtronic Vascular
- PMA number
- P070007
- Supplement
- S021
- Product code
- MIH
- Decision date
- 2010-10-26
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR TWO NEW LONGER LENGTH PROXIMAL MAIN STENT GRAFTS, THE NEW CAPTIVIA DELIVERY SYSTEM, AND A NEW STERILIZATION SITE.
Current openFDA PMA Record
- Device
- TALENT THORACIC STENT GRAFT SYSTEM
- Applicant
- Medtronic Vascular
- PMA number
- P070007
- Supplement
- S021
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2010-10-26
- Decision code
- APPR
- Date received
- 2010-08-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR TWO NEW LONGER LENGTH PROXIMAL MAIN STENT GRAFTS, THE NEW CAPTIVIA DELIVERY SYSTEM, AND A NEW STERILIZATION SITE.