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SAPIEN 3 Ultra delivery system

Edwards Lifesciences LLC · Model 9630TF29 · UDI-DI 00690103201260

NPUNPT
0
510(k) clearances
1,930
Adverse events (415 deaths)
0
Recalls
18
Facilities

Description

U.S. Edwards SAPIEN 3 Ultra Delivery System (29mm)

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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.