PMA P030054S446

Device: Avant (CDHFA700Q, CDHFA700B, CDHFA700D, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800B, CDHFA800D, CDHFA800T, CDHFA600Q,
Applicant: ABBOTT MEDICAL
PMA number: P030054
Supplement: S446
Product code: NIK
Decision date: 2026-08-12
Classification: Cardiovascular
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: the addition of alternative suppliers for the patient notifier and boot with heat shield device components used in ICD and CRT-D devices

Current openFDA PMA Record#

Device: Avant (CDHFA700Q, CDHFA700B, CDHFA700D, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800B, CDHFA800D, CDHFA800T, CDHFA600Q,
Applicant: ABBOTT MEDICAL
PMA number: P030054
Supplement: S446
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2026-08-12
Decision code: OK30
Date received: 2026-07-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the addition of alternative suppliers for the patient notifier and boot with heat shield device components used in ICD and CRT-D devices