- Device
- Home Monitoring System Version 3.52.0
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S131
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- 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