PMA P030054S402
- Device
- Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S402
- Product code
- NIK
- Decision date
- 2022-09-09
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Implement an automated weighing system at the battery supplier.
Current openFDA PMA Record#
- Device
- Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S402
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2022-09-09
- Decision code
- OK30
- Date received
- 2022-08-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement an automated weighing system at the battery supplier.