- Device
- Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S398
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2022-05-17
- Decision code
- APPR
- Date received
- 2022-03-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for Merlin Patient Care System (PCS) 3650 Model 3330 v25.8.1 software andMerlin 2 PCS Model MER3400 vl.8.1 software to improve the accuracy of the remaining battery longevity estimate by the programmer.