- Device
- Home Monitoring System Version 3.48
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S117
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2020-11-05
- Decision code
- APPR
- Date received
- 2020-08-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to introduce a physician notification system component under the current Home Monitoring System, Version 3.49.