PMA P070008S182

Device: Edora 8 HF-T QP Edora 8 HF-T Evity 8 HF-T QP Evity 8 HF-T Enitra 8 HF-T QP Enitra 8 HF-T Enticos 8 HF-T QP Enticos 8 HF-
Applicant: Biotronik, Inc.
PMA number: P070008
Supplement: S182
Product code: NKE
Decision date: 2026-10-05
Classification: Cardiovascular
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: to qualify an additional supplier of battery housing components

Current openFDA PMA Record#

Device: Edora 8 HF-T QP Edora 8 HF-T Evity 8 HF-T QP Evity 8 HF-T Enitra 8 HF-T QP Enitra 8 HF-T Enticos 8 HF-T QP Enticos 8 HF-
Applicant: Biotronik, Inc.
PMA number: P070008
Supplement: S182
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2026-10-05
Decision code: OK30
Date received: 2026-09-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to qualify an additional supplier of battery housing components