PMA P110011S005

Device
ASSURANT COBALT
Applicant
Medtronic, Ireland
PMA number
P110011
Supplement
S005
Product code
NIO
Decision date
2013-12-12
Classification
Stent, Iliac
Generic name
STENT, ILIAC
Approval order statement
CONSOLIDATE AND TRANSFER EXTRUSION ACTIVITIES TO THE SANTA ROSA, CA FACILITY.

Current openFDA PMA Record#

Device
ASSURANT COBALT
Applicant
Medtronic, Ireland
PMA number
P110011
Supplement
S005
Product code
NIO
Generic name
STENT, ILIAC
Decision date
2013-12-12
Decision code
OK30
Date received
2013-11-15
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CONSOLIDATE AND TRANSFER EXTRUSION ACTIVITIES TO THE SANTA ROSA, CA FACILITY.