PMA P070008S166

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: S166
Product code: NKE
Decision date: 2025-02-20
Classification: Cardiovascular
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: alternative supplier for manufacture of a subcomponent of medium-rate and high-rate batteries contained in implantable pulse generators (IPGs) and implantable cardioverter defibrillators (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, Enticos 8 HF-T QP, Entico
Applicant: Biotronik, Inc.
PMA number: P070008
Supplement: S166
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2025-02-20
Decision code: OK30
Date received: 2025-01-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: alternative supplier for manufacture of a subcomponent of medium-rate and high-rate batteries contained in implantable pulse generators (IPGs) and implantable cardioverter defibrillators (ICDs)