PMA P050023S197
- Device
- CardioMessenger Smart 4G
- Applicant
- Biotronik, Inc.
- PMA number
- P050023
- Supplement
- S197
- Product code
- OSR
- Decision date
- 2025-08-22
- Classification
- Cardiovascular
- Generic name
- Pacemaker/icd/crt non-implanted components
- 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
- S197
- Product code
- OSR
- Generic name
- Pacemaker/icd/crt non-implanted components
- Decision date
- 2025-08-22
- Decision code
- APPR
- Date received
- 2025-05-28
- 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