PMA P110019S107

Device: Xience Xpedition Everolimus Eluting Coronary Stent System and Xience Alpine Everolimus Eluting Coronary Stent System
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S107
Product code: NIQ
Decision date: 2019-09-10
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: Modification to the annual stability study for XIENCE Xpedition and XIENCE Alpine family of everolimus eluting coronary stent systems.

Current openFDA PMA Record#

Device: Xience Xpedition Everolimus Eluting Coronary Stent System and Xience Alpine Everolimus Eluting Coronary Stent System
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S107
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2019-09-10
Decision code: OK30
Date received: 2019-08-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Modification to the annual stability study for XIENCE Xpedition and XIENCE Alpine family of everolimus eluting coronary stent systems.