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SAPIEN 3 Ultra System
Edwards Lifesciences LLC · Model 9750CM23 · UDI-DI 00690103207828
0
510(k) clearances
1,930
Adverse events (415 deaths)
0
Recalls
18
Facilities
Description
SAPIEN 3 Ultra valve with Commander delivery System
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Get your free API keyRead the docsData 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.