PMA P070027S031

Device
TALENT ENDOLUMINALOCCLUDER SYSTEM
Applicant
Medtronic Vascular
PMA number
P070027
Supplement
S031
Product code
MIH
Decision date
2011-09-07
Classification
System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
CHANGE TO THE FIRM¿S STERILIZATION PROCESS.

Current openFDA PMA Record#

Device
TALENT ENDOLUMINALOCCLUDER SYSTEM
Applicant
Medtronic Vascular
PMA number
P070027
Supplement
S031
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2011-09-07
Decision code
OK30
Date received
2011-08-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE TO THE FIRM¿S STERILIZATION PROCESS.