FDA.reportPublic FDA data

PMA P880086S308

Device
Assurity, Assurity+, Endurity, Accent family of Pacemakers
Applicant
ABBOTT MEDICAL
Product code
DXY
Decision date
2020-06-30
Generic name
implantable pacemaker Pulse-generator
Approval order statement
Approval for Avant, Neutrino NxT, Gallant, and Entrant families of ICDs and CRT-Ds; myMerlinPulse mobile application; Merlin PCS 3650 Programmer Software Model 3330 v25.0.1; and Merlin.net MN5000 v7.8.

Current openFDA PMA Record#

Device
Assurity, Assurity+, Endurity, Accent family of Pacemakers
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S308
Product code
DXY
Generic name
implantable pacemaker Pulse-generator
Decision date
2020-06-30
Decision code
APPR
Date received
2019-11-08
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for Avant, Neutrino NxT, Gallant, and Entrant families of ICDs and CRT-Ds; myMerlinPulse mobile application; Merlin PCS 3650 Programmer Software Model 3330 v25.0.1; and Merlin.net MN5000 v7.8.