PMA P070007S028

Device
Talent Thoracic Stent Graft System
Applicant
Medtronic Vascular
PMA number
P070007
Supplement
S028
Decision date
2011-03-03

Current openFDA PMA Record

Device
TALENT THORACIC STENT GRAFT SYSTEM
Applicant
Medtronic Vascular
PMA number
P070007
Supplement
S028
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2011-03-03
Decision code
OK30
Date received
2011-02-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF A LUBRICANT DURING ASSEMBLY OF THE CAPTIVA DELIVERY SYSTEM.

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