device pma

Guidant Corp. — Accolade CRT Pacemakers (CRT-Ps): VALITUDE CRT-P U125; VALITUDE X4 CRT-P Model U128; VISIONIST CRT-P Models U225, U226 (PMA supplement)

January 8, 2026$GDNTupdated 4mo ago

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Supplement type: 135 Review Track For 30-Day Notice. Product code: NKE. Advisory committee: CV. Decision: APPR

Guidant Corp. — Accolade CRT  Pacemakers (CRT-Ps): VALITUDE CRT-P U125; VALITUDE X4 CRT-P Model U128; VISIONIST CRT-P Models U225, U226 (PMA supplement)