device pma
saveGuidant Corp. — VALITUDE (Model U125); VALITUDE X4 (Model U128); VISIONIST (Models U225, U226); VISIONIST X4 (Model U228) (PMA supplement)
community read0 votes
Supplement type: 30-Day Notice. Product code: NKE. Advisory committee: CV. Decision: OK30
view source ↗Data sources
last refreshed 5mo ago
Found something off?
same company · ±60 days · 3
- 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. — Accolade CRT Pacemakers (CRT-Ps): VALITUDE CRT-P U125; VALITUDE X4 CRT-P Model U128; VISIONIST CRT-P Models U225, U226 (PMA supplement)Jan 8, 2026
- device pmaGuidant Corp. — U125 VALITUDE CRT-P,U128 VALITUDE X4 CRT-P,U225 VISIONIST CRT-P,U226 VISIONIST CRT-P,U228 VISIONIST X4 CRT-P (PMA supplement)Oct 22, 2025
comments(0)
5-min edit window · permanent after that