device pma

Medtronic, Inc. — Avalus Bioprosthesis Model 400 (40019, 40021, 40023, 40025, 40027, 40029); Avalus Ultra Bioprosthesis Model 400 (400U1 (PMA supplement)

February 4, 2026$MDTupdated 2mo ago

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Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30

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Medtronic, Inc. — Avalus Bioprosthesis Model 400 (40019, 40021, 40023, 40025, 40027, 40029); Avalus Ultra Bioprosthesis Model 400 (400U1 (PMA supplement)