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EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)

Edwards Lifesciences LLC · Model 9600TFX · UDI-DI 00690103194340

NPUNPTNPV
0
510(k) clearances
2,032
Adverse events (426 deaths)
0
Recalls
18
Facilities

Description

EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (23MM)

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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.