PMA P070008S172

Device: Edora 8 HF-T QP 407137 Edora 8 HF-T 407138 Evity 8 HF-T QP 407139 Evity 8 HF-T 407140 Enitra 8 HF-T QP 407141 Enitra 8 H
Applicant: Biotronik, Inc.
PMA number: P070008
Supplement: S172
Product code: NKE
Decision date: 2026-09-25
Classification: Cardiovascular
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: the next generation of the Home Monitoring Service Center (HMSC)

Current openFDA PMA Record#

Device: Edora 8 HF-T QP 407137 Edora 8 HF-T 407138 Evity 8 HF-T QP 407139 Evity 8 HF-T 407140 Enitra 8 HF-T QP 407141 Enitra 8 H
Applicant: Biotronik, Inc.
PMA number: P070008
Supplement: S172
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2026-09-25
Decision code: APPR
Date received: 2025-09-25
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: the next generation of the Home Monitoring Service Center (HMSC)