PMA P070007S034
- Device
- TALENT CAPTIVIA STENT GRAFT SYSTEM
- Applicant
- Medtronic Vascular
- PMA number
- P070007
- Supplement
- S034
- Product code
- MIH
- Decision date
- 2012-03-05
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR LABELING CHANGES AND A CHANGE IN THE GRAFT LOADING PROCESS.
Current openFDA PMA Record
- Device
- TALENT CAPTIVIA STENT GRAFT SYSTEM
- Applicant
- Medtronic Vascular
- PMA number
- P070007
- Supplement
- S034
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2012-03-05
- Decision code
- APPR
- Date received
- 2012-02-07
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES AND A CHANGE IN THE GRAFT LOADING PROCESS.