PMA P070008S168

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: S168
Product code: NKE
Decision date: 2025-06-18
Classification: Cardiovascular
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: to change the material of the feedthrough component of pacemaker and ICD batteries

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, Enitr
Applicant: Biotronik, Inc.
PMA number: P070008
Supplement: S168
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2025-06-18
Decision code: OK30
Date received: 2025-05-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to change the material of the feedthrough component of pacemaker and ICD batteries