PMA P950037S240
- Device
- DataBridge 4G/LTE Adapter
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S240
- Product code
- DXY
- Decision date
- 2022-12-02
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Approval for the use of the DataBridge 4G/LTE adapter with the Renamic Programmer.
Current openFDA PMA Record#
- Device
- DataBridge 4G/LTE Adapter
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S240
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2022-12-02
- Decision code
- APPR
- Date received
- 2022-09-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the use of the DataBridge 4G/LTE adapter with the Renamic Programmer.