- Device
- Avant HF, Neutrino NxT HF, Gallant HF and Entrant HF CRT-D
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S381
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2020-09-15
- Decision code
- APPR
- Date received
- 2020-07-09
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for use of a pre-molded header utilizing a one-piece contact assembly in lieu of a two-piece contact assembly.