PMA P020047S066

Device: MULTI-LINK 8 Coronary Stent System / SV / LL Coronary Stent System
Applicant: Abbott Vascular
PMA number: P020047
Supplement: S066
Product code: MAF
Decision date: 2018-01-25
Classification: Stent, Coronary
Generic name: STENT, CORONARY
Approval order statement: Approval to change the ethylene oxide (EO) sterilization release process for the affected products from using the traditional method of biological indicator testing to a parametric release process.

Current openFDA PMA Record#

Device: MULTI-LINK 8 Coronary Stent System / SV / LL Coronary Stent System
Applicant: Abbott Vascular
PMA number: P020047
Supplement: S066
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 2018-01-25
Decision code: APPR
Date received: 2017-09-28
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval to change the ethylene oxide (EO) sterilization release process for the affected products from using the traditional method of biological indicator testing to a parametric release process.