PMA P110019S020

Device: XIENCE XPEDITION, XIENCE XPEDITION SV, AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S020
Product code: NIQ
Decision date: 2012-09-19
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: APPROVAL TO CHANGE THE COATING INTEGRITY SPECIFICATION FOR THE 28 MM LENGTH STENTS TO ALIGN WITH THAT OF THE 33 MM AND 38 MM STENTS FOR THE XIENCE FAMILY OF PRODUCTS.

Current openFDA PMA Record#

Device: XIENCE XPEDITION, XIENCE XPEDITION SV, AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S020
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2012-09-19
Decision code: APPR
Date received: 2012-06-19
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO CHANGE THE COATING INTEGRITY SPECIFICATION FOR THE 28 MM LENGTH STENTS TO ALIGN WITH THAT OF THE 33 MM AND 38 MM STENTS FOR THE XIENCE FAMILY OF PRODUCTS.