PMA P910023S400
- Device
- Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+family of ICDS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S400
- Product code
- LWS
- Decision date
- 2018-04-11
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for cybersecurity updates and implementation of a Battery Performance Alert in the firmware of ICDs and CRT-Ds.
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
- S400
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-04-11
- Decision code
- APPR
- Date received
- 2018-01-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for cybersecurity updates and implementation of a Battery Performance Alert in the firmware of ICDs and CRT-Ds.