PMA P980023S102
- Device
- Home Monitoring System Version 3.48
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S102
- Product code
- LWS
- Decision date
- 2020-11-05
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval to introduce a physician notification system component under the current Home Monitoring System, Version 3.49.
Current openFDA PMA Record#
- Device
- Home Monitoring System Version 3.48
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S102
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- 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.