- Device
- XIENCE Xpedition Everolimus Eluting Coronary Stent System, SV (2.25), LL; XIENCE Alpine Everolimus Eluting Coronary Sten
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S098
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2018-05-30
- Decision code
- APPR
- Date received
- 2018-03-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the implementation of everolimus BHT manufactured at a new manufacturing site.