PMA P070007S035

Device: TALENT THORACIC STENT GRAFT SYSTEM WITH THE XCELERANT AND CAPTIVA DELIVERY SYSTEM
Applicant: Medtronic Vascular
PMA number: P070007
Supplement: S035
Product code: MIH
Decision date: 2012-08-16
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL FOR A CHANGE TO AUTOMATE THE INFORMATION MANAGEMENT SYSTEM.

Current openFDA PMA Record

Device: TALENT THORACIC STENT GRAFT SYSTEM WITH THE XCELERANT AND CAPTIVA DELIVERY SYSTEM
Applicant: Medtronic Vascular
PMA number: P070007
Supplement: S035
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2012-08-16
Decision code: APPR
Date received: 2012-03-22
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE TO AUTOMATE THE INFORMATION MANAGEMENT SYSTEM.