PMA P110043S015

Device: Omnilink Elite Vascular Balloon-Expandable Stent System
Applicant: Abbott Vascular-Cardiac Therapies
PMA number: P110043
Supplement: S015
Product code: NIO
Decision date: 2026-01-12
Classification: Cardiovascular
Generic name: STENT, ILIAC
Approval order statement: Approval for updates to the device Instructions for Use (IFU) and patient guide including updates to the contraindications, warnings, precautions, procedural updates, and MRI Safety information

Current openFDA PMA Record#

Device: Omnilink Elite Vascular Balloon-Expandable Stent System
Applicant: Abbott Vascular-Cardiac Therapies
PMA number: P110043
Supplement: S015
Product code: NIO
Generic name: STENT, ILIAC
Decision date: 2026-01-12
Decision code: APPR
Date received: 2025-12-17
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for updates to the device Instructions for Use (IFU) and patient guide including updates to the contraindications, warnings, precautions, procedural updates, and MRI Safety information