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FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first

The Tracker / September 2026 / P250050

PMA approved

Liverty TIPS Stent Graft

Bard Peripheral Vascular, Inc. · Sep 25, 2026 · P250050

FDA approved the Liverty TIPS Stent Graft from Bard Peripheral Vascular, Inc. on Sep 25, 2026 under P250050, an original premarket approval. The device falls under product code MIR, Shunt, Portosystemic, Endoprosthesis as a Class 3 device. The review panel was Cardiovascular.

FDA logged the submission as received on Nov 26, 2025. The decision came 303 days later.

Bard Peripheral Vascular, Inc. has 3 other decisions in the tracker over the last 12 months: K262571 (EnCor EnCompass Breast Biopsy and Tissue Removal System), K260012 (UltraScore Focused Force PTA Balloon), K252681 (EnCor EnCompass Breast Biopsy and Tissue Removal System).

Questions & Answers

What did FDA approve under P250050?

P250050 is the FDA PMA for Liverty TIPS Stent Graft, submitted by Bard Peripheral Vascular, Inc.. FDA's decision date was Sep 25, 2026, under product code MIR (Shunt, Portosystemic, Endoprosthesis).

Who makes the Liverty TIPS Stent Graft?

Bard Peripheral Vascular, Inc., based in Tempe, AZ, is the applicant of record for P250050.

How long did the P250050 review take?

FDA received the submission on Nov 26, 2025 and issued its decision on Sep 25, 2026, 303 days later.

← All decisions in September 2026

Sources