- Device
- Avant VR ICD, Avant DR ICD, Neutrino NxT VR ICD, Neutrino NxT DR ICD, Gallant VR ICD, Gallant DR ICD, Entrant VR ICD and
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S432
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- 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.