PMA P110019S068

Device: XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM- SV, AND LL
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S068
Product code: NIQ
Decision date: 2014-07-03
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: APPROVAL TO CHANGE THE OUTER LAYER THICKNESS SPECIFICATION FOR THE INNER MEMBER CATHETER COMPONENT FOR THE XIENCE XPEDITION, XIENCE XPEDITION SV, AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT OVER THE WIRE (OTW) SYSTEM.

Current openFDA PMA Record#

Device: XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM- SV, AND LL
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S068
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2014-07-03
Decision code: APPR
Date received: 2014-04-21
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO CHANGE THE OUTER LAYER THICKNESS SPECIFICATION FOR THE INNER MEMBER CATHETER COMPONENT FOR THE XIENCE XPEDITION, XIENCE XPEDITION SV, AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT OVER THE WIRE (OTW) SYSTEM.