- Device
- XIENCE Alpine Everolimus Eluting Coronary Stent System, XIENCE Sierra Everolimus Eluting Coronary Stent System, XIENCE S
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S122
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2022-09-14
- Decision code
- APPR
- Date received
- 2022-06-23
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval to extend the shelf life for the XIENCE Sierra and XIENCE Skypoint Everolimus-Eluting Coronary Stent System from 24 to 36 months and minor labeling changes for the XIENCE Sierra, Skypoint, and Alpine Everolimus-Eluting Coronary Stent System.