PMA P050023S159
- Device
- CardioMessenger Smart 4G
- Applicant
- Biotronik, Inc.
- PMA number
- P050023
- Supplement
- S159
- Product code
- MRM
- Decision date
- 2021-08-13
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- Acceptance to implement optimization of production processes for capacity expansion and to introduce a robotic arm for automated device transfer.
Current openFDA PMA Record#
- Device
- CardioMessenger Smart 4G
- Applicant
- Biotronik, Inc.
- PMA number
- P050023
- Supplement
- S159
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2021-08-13
- Decision code
- OK30
- Date received
- 2021-07-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Acceptance to implement optimization of production processes for capacity expansion and to introduce a robotic arm for automated device transfer.