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SAPIEN 3 Ultra RESILIA

Edwards Lifesciences LLC · Model 9755RSL29 · UDI-DI 00690103215823

NPU NPT Prescription

510(k) clearances

1,972

Adverse events (417 deaths)

Recalls

Facilities

Description

SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, 29mm

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.