FDA.reportPublic FDA data

PMA P020047S072

Device
MULTI-LINK 8, MULTI-LINK 8 SV/LL CORONARY STENT SYSTEMS
Applicant
Abbott Vascular
PMA number
P020047
Supplement
S072
Product code
MAF
Decision date
2020-03-19
Generic name
STENT, CORONARY
Approval order statement
Approval for changing the ethylene oxide (EO) sterilization release process for the affected products from the traditional method of biological indicator testing to a parametric release process.

Current openFDA PMA Record#

Device
MULTI-LINK 8, MULTI-LINK 8 SV/LL CORONARY STENT SYSTEMS
Applicant
Abbott Vascular
PMA number
P020047
Supplement
S072
Product code
MAF
Generic name
STENT, CORONARY
Decision date
2020-03-19
Decision code
APPR
Date received
2019-09-26
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for changing the ethylene oxide (EO) sterilization release process for the affected products from the traditional method of biological indicator testing to a parametric release process.