FDA.reportPublic FDA data

PMA P020047S065

Device
Multi-Link 8 Coronary Stent System
Applicant
Abbott Vascular
PMA number
P020047
Supplement
S065
Product code
MAF
Decision date
2017-12-15
Classification
Stent, Coronary
Generic name
STENT, CORONARY
Approval order statement
Approval for a manufacturing site located at Sterigenics UK Limited, Cotes Park Estate, Somercotes, Derbeyshire DE55 4NJ, United Kingdom, for sterilization of Multi-Link 8 / Multi-Link 8LL / Multi-Link 8SV Coronary Stent System manufactured at Abbott Vascular’s Clonmel, Ireland facility.

Current openFDA PMA Record#

Device
Multi-Link 8 Coronary Stent System
Applicant
Abbott Vascular
PMA number
P020047
Supplement
S065
Product code
MAF
Generic name
STENT, CORONARY
Decision date
2017-12-15
Decision code
APPR
Date received
2017-06-05
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a manufacturing site located at Sterigenics UK Limited, Cotes Park Estate, Somercotes, Derbeyshire DE55 4NJ, United Kingdom, for sterilization of Multi-Link 8 / Multi-Link 8LL / Multi-Link 8SV Coronary Stent System manufactured at Abbott Vascular’s Clonmel, Ireland facility.