Biotronik, 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)

Supplement type: Special (Immediate Track). Product code: NVZ. Advisory committee: CV. Decision: APPR