- Device
- Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+, Avant, Entrant, Gallant and
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S447
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2022-09-30
- Decision code
- APPR
- Date received
- 2022-07-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Merlin@home transmitter software model EX2000 v9.0 and cybersecurity enhancements.