PMA P950037S296

Device: Edora 8 DR-T 407145; Evity 8 DR-T 407146; Enitra 8 DR-T 407147; Enticos 8 DR-T 407148; Evity 6 DR-T 407149; Enitra 6 DR-
Applicant: Biotronik, Inc.
PMA number: P950037
Supplement: S296
Product code: DXY
Decision date: 2026-10-09
Classification: Cardiovascular
Generic name: implantable pacemaker Pulse-generator
Approval order statement: battery separator pocket material change and new additive to battery electrolyte.

Current openFDA PMA Record#

Device: Edora 8 DR-T 407145; Evity 8 DR-T 407146; Enitra 8 DR-T 407147; Enticos 8 DR-T 407148; Evity 6 DR-T 407149; Enitra 6 DR-
Applicant: Biotronik, Inc.
PMA number: P950037
Supplement: S296
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 2026-10-09
Decision code: APPR
Date received: 2026-07-13
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: battery separator pocket material change and new additive to battery electrolyte.