- Device
- Avant VR; Neutrino NxT VR; Gallant VR; Neutrino NxT VR; Entrant VR; Avant DR; Neutrino NxT DR; Gallant DR; Neutrino NxT
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S442
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- 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.