PMA P070008S171

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 Enitra 8 H
Applicant: Biotronik, Inc.
PMA number: P070008
Supplement: S171
Product code: NKE
Decision date: 2025-10-16
Classification: Cardiovascular
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: introducing an alternative supplier for a set screw component

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 Enitra 8 H
Applicant: Biotronik, Inc.
PMA number: P070008
Supplement: S171
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2025-10-16
Decision code: OK30
Date received: 2025-09-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: introducing an alternative supplier for a set screw component