PMA P070008S167

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; Entico
Applicant: Biotronik, Inc.
PMA number: P070008
Supplement: S167
Product code: NKE
Decision date: 2025-10-24
Classification: Cardiovascular
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: Approval for updates to the anode current collector manufacturing process.

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; Entico
Applicant: Biotronik, Inc.
PMA number: P070008
Supplement: S167
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2025-10-24
Decision code: APPR
Date received: 2025-03-18
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for updates to the anode current collector manufacturing process.