- 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; Enitr
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S181
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2026-10-09
- Decision code
- APPR
- Date received
- 2026-07-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- battery separator pocket material change and new additive to battery electrolyte.