- Device
- Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S437
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2021-06-28
- Decision code
- APPR
- Date received
- 2021-04-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the Merlin PCS 3650 Programmer Model 3330 Software to create v25.1.1.