PMA P070007S038

Device: TALENT THORACIC STENT GRAFT SYSTEM
Applicant: Medtronic Vascular
PMA number: P070007
Supplement: S038
Product code: MIH
Decision date: 2016-04-05
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Approval of the following changes to the post-approval study for the device: sponsor proposes to terminate its THRIVE Trial PAS due to the device no longer beingmanufactured or commercially available.

Current openFDA PMA Record

Device: TALENT THORACIC STENT GRAFT SYSTEM
Applicant: Medtronic Vascular
PMA number: P070007
Supplement: S038
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2016-04-05
Decision code: APPR
Date received: 2015-01-16
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol - OSB
Approval order statement: Approval of the following changes to the post-approval study for the device: sponsor proposes to terminate its THRIVE Trial PAS due to the device no longer beingmanufactured or commercially available.