PMA P070007S031

Device: TALENT THORACIC STENT GRAFT WITH THE CAPTIVIA AND WITH THE XCELERANT DELIVERY SYSTEM
Applicant: Medtronic Vascular
PMA number: P070007
Supplement: S031
Product code: MIH
Decision date: 2011-07-13
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: REDUCTION IN THE NUMBER OF IN-PROCESS INSPECTION STEPS IN TWO MANUFACTURING PROCESSES OF THE DELIVERY SYSTEMS.

Current openFDA PMA Record

Device: TALENT THORACIC STENT GRAFT WITH THE CAPTIVIA AND WITH THE XCELERANT DELIVERY SYSTEM
Applicant: Medtronic Vascular
PMA number: P070007
Supplement: S031
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2011-07-13
Decision code: OK30
Date received: 2011-06-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: REDUCTION IN THE NUMBER OF IN-PROCESS INSPECTION STEPS IN TWO MANUFACTURING PROCESSES OF THE DELIVERY SYSTEMS.