PMA P070007S017

Device: TALENT THORACIC GRAFT SYSTEM
Applicant: Medtronic Vascular
PMA number: P070007
Supplement: S017
Product code: MIH
Decision date: 2010-04-30
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL FOR LABELING CHANGES REGARDING OVER SIZING BEYOND CURRENT RECOMMENDATIONS AND THE PLACEMENT OF BARE SPRINGS INSIDE OF COVERED STENT GRAFTS.

Current openFDA PMA Record

Device: TALENT THORACIC GRAFT SYSTEM
Applicant: Medtronic Vascular
PMA number: P070007
Supplement: S017
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2010-04-30
Decision code: APPR
Date received: 2010-04-07
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR LABELING CHANGES REGARDING OVER SIZING BEYOND CURRENT RECOMMENDATIONS AND THE PLACEMENT OF BARE SPRINGS INSIDE OF COVERED STENT GRAFTS.