device pma
saveBiotronik, Inc. — Edora 8 DR-T; Evity 8 DR-T; Enitra 8 DR-T; Enticos 8 DR-T; Evity 6 DR-T; Enitra 6 DR-T; Edora 8 DR; Enitra 6 DR; Edora 8 (PMA supplement)
October 24, 2025updated 3mo ago
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Supplement type: 135 Review Track For 30-Day Notice. Product code: DXY. Advisory committee: CV. Decision: APPR
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