PMA P950037S229
- Device
- Home Monitoring System Version 3.52.0
- Applicant
- Biotronik, Inc.
- Product code
- DXY
- Decision date
- 2025-04-15
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- approval for the HeartInsight feature, a heart failure management solution in Biotronik’s Home Monitoring System Version 3.42.0
Current openFDA PMA Record#
- Device
- Home Monitoring System Version 3.52.0
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S229
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2025-04-15
- Decision code
- APPR
- Date received
- 2021-09-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for the HeartInsight feature, a heart failure management solution in Biotronik’s Home Monitoring System Version 3.42.0