PMA P030054S399
- Device
- Avant HF, Neutrino NxT HF, Gallant HF, and Entrant HF
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S399
- Product code
- NIK
- Decision date
- 2022-07-14
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Second-tier supplier's manufacturing site transfer.
Current openFDA PMA Record#
- Device
- Avant HF, Neutrino NxT HF, Gallant HF, and Entrant HF
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S399
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2022-07-14
- Decision code
- OK30
- Date received
- 2022-07-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Second-tier supplier's manufacturing site transfer.