PMA P030054S443
- Device
- Avant (CDHFA700Q, CDHFA700B, CDHFA700D, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800B, CDHFA800D, CDHFA800T); Gallant (
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S443
- Product code
- NIK
- Decision date
- 2026-03-27
- Classification
- Cardiovascular
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Current openFDA PMA Record#
- Device
- Avant (CDHFA700Q, CDHFA700B, CDHFA700D, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800B, CDHFA800D, CDHFA800T); Gallant (
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S443
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2026-03-27
- Decision code
- OK30
- Date received
- 2026-02-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier