PMA P050023S164
- Device
- CardioMessenger Smart 4G
- Applicant
- Biotronik, Inc.
- PMA number
- P050023
- Supplement
- S164
- Product code
- MRM
- Decision date
- 2022-01-27
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- Approval for a new version of the cellular modem used in the CardioMessenger Smart 4G device.
Current openFDA PMA Record#
- Device
- CardioMessenger Smart 4G
- Applicant
- Biotronik, Inc.
- PMA number
- P050023
- Supplement
- S164
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2022-01-27
- Decision code
- APPR
- Date received
- 2021-10-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a new version of the cellular modem used in the CardioMessenger Smart 4G device.