- Device
- Avant (CDVRA700Q, CDVRA700T); Neutrino NxT (CDVRA800Q, CDVRA800T, CDVRA600Q, CDVRA600T); Gallant (CDVRA500Q, CDVRA500T);
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S486
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2026-07-09
- Decision code
- OK30
- Date received
- 2026-06-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementing an alternate supplier of MOSFET subcomponent and associated minor manufacturing changes