- Device
- Avant HF; Neutrino NxT HF; Gallant HF; Neutrino NxT HF; Entrant HF;
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S397
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2022-01-13
- Decision code
- APPR
- Date received
- 2021-10-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for firmware updates for Avant, Neutrino NxT, Gallant, and Entrant families of ICDs and CRT-Ds.