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Biotronik, Inc.

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories5
Latest Approval2026-05-15
TypeNumberDevice NameCodeDate
PMA P950037 implantable pacemaker Pulse-generator DXY 2026-05-15 View
PMA P980023 Implantable cardioverter defibrillator (non-CRT) LWS 2026-05-07 View
PMA P950037 implantable pacemaker Pulse-generator DXY 2026-05-07 View
PMA P050023 DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM 2026-05-07 View
PMA P070008 Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) NKE 2026-05-07 View
PMA P000009 DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM 2026-05-07 View
510(k) K261074 BIOMONITOR IV (471155) MXD 2026-05-01 View
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