PMA P910023S485

Device
Avant (CDVRA700Q, CDDRA700Q, CDVRA700T, CDDRA700T); Neutrino NxT (CDVRA800Q, CDVRA600Q CDDRA800Q, CDDRA600Q CDVRA600T, C
Applicant
ABBOTT MEDICAL
PMA number
P910023
Supplement
S485
Product code
LWS
Decision date
2026-03-27
Classification
Cardiovascular
Generic name
Implantable cardioverter defibrillator (non-CRT)

Current openFDA PMA Record#

Device
Avant (CDVRA700Q, CDDRA700Q, CDVRA700T, CDDRA700T); Neutrino NxT (CDVRA800Q, CDVRA600Q CDDRA800Q, CDDRA600Q CDVRA600T, C
Applicant
ABBOTT MEDICAL
PMA number
P910023
Supplement
S485
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2026-03-27
Decision code
OK30
Date received
2026-02-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier