- Device
- Avant (CDVRA700Q, CDDRA700Q, CDVRA700T, CDDRA700T); Neutrino NxT (CDVRA800Q, CDVRA600Q, CDDRA800Q, CDDRA600Q, CDVRA600T,
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S487
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2026-08-12
- Decision code
- OK30
- Date received
- 2026-07-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of alternative suppliers for the patient notifier and boot with heat shield device components used in ICD and CRT-D devices