PMA P020047S067

Device: MULTI-LINK 8 Coronary, 8 LL Coronary, and 8 SV Coronary Stent System
Applicant: Abbott Vascular
PMA number: P020047
Supplement: S067
Product code: MAF
Decision date: 2018-03-05
Classification: Stent, Coronary
Generic name: STENT, CORONARY
Approval order statement: Approval for an alternate contract sterilizer site located at Synergy Heath Ireland Ltd, IDA Business & Technology Park, Sragh Industrial Estate, Tullamore, Co. Offaly, Ireland. To perform as an alternate ethylene oxide sterilization vendor for the GRAFTMASTER Coronary Stent Graft System, MULTI-LINK 8 Coronary, 8 LL Coronary, and 8 SV Coronary Stent System, XIENCE V and Nano Everolimus Eluting Coronary Stent System, and XIENCE Prime/Xpedition/Alpine/Sierra Everolimus Eluting Coronary Stent System (SV, LL).

Current openFDA PMA Record#

Device: MULTI-LINK 8 Coronary, 8 LL Coronary, and 8 SV Coronary Stent System
Applicant: Abbott Vascular
PMA number: P020047
Supplement: S067
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 2018-03-05
Decision code: APPR
Date received: 2017-12-11
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for an alternate contract sterilizer site located at Synergy Heath Ireland Ltd, IDA Business & Technology Park, Sragh Industrial Estate, Tullamore, Co. Offaly, Ireland. To perform as an alternate ethylene oxide sterilization vendor for the GRAFTMASTER Coronary Stent Graft System, MULTI-LINK 8 Coronary, 8 LL Coronary, and 8 SV Coronary Stent System, XIENCE V and Nano Everolimus Eluting Coronary Stent System, and XIENCE Prime/Xpedition/Alpine/Sierra Everolimus Eluting Coronary Stent System (SV, LL).