PMA P070008S183

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
Applicant: Biotronik, Inc.
PMA number: P070008
Supplement: S183
Product code: NKE
Decision date: 2026-10-13
Classification: Cardiovascular
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: a change to the rework process for the manufacturing of the housing for pulse generators and ICDS

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
Applicant: Biotronik, Inc.
PMA number: P070008
Supplement: S183
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2026-10-13
Decision code: OK30
Date received: 2026-09-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a change to the rework process for the manufacturing of the housing for pulse generators and ICDS