FDA.reportPublic FDA data

PMA P020047S068

Device
MULTI-LINK 8 Coronary Stent System and SV/LL Coronary Stent System
Applicant
Abbott Vascular
PMA number
P020047
Supplement
S068
Product code
MAF
Decision date
2018-02-21
Classification
Stent, Coronary
Generic name
STENT, CORONARY
Approval order statement
Change the time point when pyrogen testing for ethylene oxide (EO) sterilized products is conducted for products manufactured at its facility located in Clonmel, Ireland.

Current openFDA PMA Record#

Device
MULTI-LINK 8 Coronary Stent System and SV/LL Coronary Stent System
Applicant
Abbott Vascular
PMA number
P020047
Supplement
S068
Product code
MAF
Generic name
STENT, CORONARY
Decision date
2018-02-21
Decision code
OK30
Date received
2018-01-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change the time point when pyrogen testing for ethylene oxide (EO) sterilized products is conducted for products manufactured at its facility located in Clonmel, Ireland.