device pma
saveGuidant Corp. — Accolade CRT Pacemakers (CRT-Ps): VALITUDE CRT-P U125; VALITUDE X4 CRT-P Model U128; VISIONIST CRT-P Models U225, U226 (PMA supplement)
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Supplement type: 135 Review Track For 30-Day Notice. Product code: NKE. Advisory committee: CV. Decision: APPR
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- device pmaGuidant Corp. — VALITUDE (Model U125) VALITUDE X4 (Model U128) VISIONIST (Models U225, U226) VISIONIST X4 (Model U228) Firmware Vers (PMA supplement)Dec 19, 2025
- device pmaGuidant Corp. — VALITUDE (Model U125); VALITUDE X4 (Model U128); VISIONIST (Models U225, U226); VISIONIST X4 (Model U228) (PMA supplement)Dec 17, 2025
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