PMA P910023S484
- Device
- Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S484
- Product code
- LWS
- Decision date
- 2026-04-24
- Classification
- Cardiovascular
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- the Merlin PCS Programmer Software Model 3330 version 28.8.1
Current openFDA PMA Record#
- Device
- Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S484
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2026-04-24
- Decision code
- APPR
- Date received
- 2026-01-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- the Merlin PCS Programmer Software Model 3330 version 28.8.1