FDA.reportPublic FDA data

PMA P110019S112

Device
XIENCE Sierra Stent System
Applicant
Abbott Vascular
PMA number
P110019
Supplement
S112
Product code
NIQ
Decision date
2020-10-22
Generic name
Coronary drug-eluting stent
Approval order statement
Approval for extending the shelf-life for the XIENCE Sierra Everolimus-Eluting Coronary Stent System from 18 to 24 months and to revise the annual stability testing protocol to align with the other XIENCE stent family members.

Current openFDA PMA Record#

Device
XIENCE Sierra Stent System
Applicant
Abbott Vascular
PMA number
P110019
Supplement
S112
Product code
NIQ
Generic name
Coronary drug-eluting stent
Decision date
2020-10-22
Decision code
APPR
Date received
2020-07-24
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for extending the shelf-life for the XIENCE Sierra Everolimus-Eluting Coronary Stent System from 18 to 24 months and to revise the annual stability testing protocol to align with the other XIENCE stent family members.