- Device
- Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos 4 DR, Enticos
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S298
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2026-10-13
- Decision code
- OK30
- Date received
- 2026-09-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the rework process for the manufacturing of the housing for pulse generators and ICDS