Biotronik, Inc. — Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T (407149); En (PMA supplement)

Supplement type: 30-Day Notice. Product code: DXY. Advisory committee: CV. Decision: OK30