- 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
- S273
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2025-06-18
- Decision code
- OK30
- Date received
- 2025-05-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to change the material of the feedthrough component of pacemaker and ICD batteries