PMA P070008S170

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: S170
Product code: NKE
Decision date: 2025-09-15
Classification: Cardiovascular
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: updates to the communication tool used in the manufacturing of IPGs and ICDs

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: S170
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2025-09-15
Decision code: OK30
Date received: 2025-08-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: updates to the communication tool used in the manufacturing of IPGs and ICDs