PMA P110011S007

Device
ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM
Applicant
Medtronic, Ireland
PMA number
P110011
Supplement
S007
Product code
NIO
Decision date
2014-04-17
Classification
Stent, Iliac
Generic name
STENT, ILIAC
Approval order statement
CHANGES AND UPGRADES TO THE CURRENT ELECTROPOLISHING STATION.

Current openFDA PMA Record#

Device
ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM
Applicant
Medtronic, Ireland
PMA number
P110011
Supplement
S007
Product code
NIO
Generic name
STENT, ILIAC
Decision date
2014-04-17
Decision code
OK30
Date received
2014-03-18
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGES AND UPGRADES TO THE CURRENT ELECTROPOLISHING STATION.