PMA P950037S279
- 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
- S279
- Product code
- DXY
- Decision date
- 2026-09-25
- Classification
- Cardiovascular
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- the next generation of the Home Monitoring Service Center (HMSC)
Current openFDA PMA Record#
- 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
- S279
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2026-09-25
- Decision code
- APPR
- Date received
- 2025-09-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- the next generation of the Home Monitoring Service Center (HMSC)