- Device
- Avant (CDHFA700Q, CDHFA700T, CDHFA700D); Neutrino NxT (CDHFA800Q, CDHFA800T, CDHFA800B, CDHFA800D, CDHFA600Q, CDHFA600T,
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S445
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2026-07-09
- Decision code
- OK30
- Date received
- 2026-06-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementing an alternate supplier of MOSFET subcomponent and associated minor manufacturing changes