PMA P110019S135

Device: Xience Skypoint Everolimus Eluting Coronary Stent System; XIENCE Alpine Everolimus Coronary Stent System; XIENCE Sierra
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S135
Product code: NIQ
Decision date: 2025-05-19
Classification: Cardiovascular
Generic name: Coronary drug-eluting stent
Approval order statement: shelf life extension for XIENCE Skypoint 48 in diameters 2.5- 4.0 mm and labeling updates to the XIENCE Family of Stents

Current openFDA PMA Record#

Device: Xience Skypoint Everolimus Eluting Coronary Stent System; XIENCE Alpine Everolimus Coronary Stent System; XIENCE Sierra
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S135
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2025-05-19
Decision code: APPR
Date received: 2025-02-18
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: shelf life extension for XIENCE Skypoint 48 in diameters 2.5- 4.0 mm and labeling updates to the XIENCE Family of Stents