PMA P950037

Device: Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8
Applicant: Biotronik, Inc.
PMA number: P950037
Supplement: S243
Product code: DXY
Decision date: 2026-10-22
Generic name: implantable pacemaker Pulse-generator
Approval order statement: updating visual and dimensional incoming inspection testing for certain components and raw materials used in IPG, ICD, and lead manufacturing

Current openFDA PMA Record#

Device: Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8
Applicant: Biotronik, Inc.
PMA number: P950037
Supplement: S299
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 2026-10-22
Decision code: OK30
Date received: 2026-09-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: updating visual and dimensional incoming inspection testing for certain components and raw materials used in IPG, ICD, and lead manufacturing