- Device
- XIENCE Sierra Everolimus Eluting Coronary Stent System
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S114
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2020-12-16
- Decision code
- APPR
- Date received
- 2020-11-16
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing site located at Abbott Vascular, 26531 Ynez Road, Temecula, CA 92591, for finished product manufacturing, catheter manufacturing, and labeling.