PMA P950037S268

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: S268
Product code: DXY
Decision date: 2025-02-05
Classification: Cardiovascular
Generic name: implantable pacemaker Pulse-generator
Approval order statement: replacing the current graphite powder material with two graphite powder materials from the same sub-tier supplier

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: S268
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 2025-02-05
Decision code: OK30
Date received: 2025-01-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: replacing the current graphite powder material with two graphite powder materials from the same sub-tier supplier