- Device
- Neutrino NxT VR, Gallant VR, Entrant VR, Neutrino NxT DR, Gallant DR, Entrant DR, Avant VR, Avant DR
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S444
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2022-05-18
- Decision code
- OK30
- Date received
- 2022-04-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate supplier for the 9-pin filtered feedthrough assembly components used in ICD devices.