device pma

Guidant Corp. — VALITUDE (Model U125) VALITUDE X4 (Model U128) VISIONIST (Models U225, U226) VISIONIST X4 (Model U228) Firmware Vers (PMA supplement)

December 19, 2025$GDNTupdated 2mo ago

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Supplement type: Real-Time Process. Product code: NKE. Advisory committee: CV. Decision: APPR

Guidant Corp. — VALITUDE (Model U125) VALITUDE X4 (Model U128) VISIONIST (Models U225, U226) VISIONIST X4 (Model U228) Firmware Vers (PMA supplement)