PMA P070008S178

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, Amvia Sky HF-T, Amvia Sky
Applicant: Biotronik, Inc.
PMA number: P070008
Supplement: S178
Product code: NKE
Decision date: 2026-05-07
Classification: Cardiovascular
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: laser machine manufacturing parameter adjustments

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, Amvia Sky HF-T, Amvia Sky
Applicant: Biotronik, Inc.
PMA number: P070008
Supplement: S178
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2026-05-07
Decision code: OK30
Date received: 2026-04-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: laser machine manufacturing parameter adjustments