PMA P110019S142
- Device
- XIENCE Alpine; XIENCE Sierra; XIENCE PROs; XIENCE Skypoint Everolimus Eluting Coronary Stent Systems
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S142
- Product code
- NIQ
- Decision date
- 2026-07-31
- Classification
- Cardiovascular
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- an alternate supplier for the secondary packaging
Current openFDA PMA Record#
- Device
- XIENCE Alpine; XIENCE Sierra; XIENCE PROs; XIENCE Skypoint Everolimus Eluting Coronary Stent Systems
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S142
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2026-07-31
- Decision code
- APPR
- Date received
- 2026-05-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- an alternate supplier for the secondary packaging