- 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
- S272
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2025-10-24
- Decision code
- APPR
- Date received
- 2025-03-18
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for updates to the anode current collector manufacturing process.