- Device
- Avant HF CRT-D, Neutrino NxT HF CRT-D, Gallant HF CRT-D, and Entrant HF CRT-D
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S385
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2020-09-23
- Decision code
- OK30
- Date received
- 2020-08-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate use of the ILT Welder during the manufacturing welding process.