PMA P880086S323

Device: Assurity, Assurity+, Endurity, Accent family of Pacemakers
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S323
Product code: DXY
Decision date: 2022-05-17
Generic name: implantable pacemaker Pulse-generator
Approval order statement: Approval for Merlin Patient Care System (PCS) 3650 Model 3330 v25.8.1 software and Merlin 2 PCS Model MER3400 vl.8.1 software to improve the accuracy of the remaining battery longevity estimate by the programmer.

Current openFDA PMA Record#

Device: Assurity, Assurity+, Endurity, Accent family of Pacemakers
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S323
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 2022-05-17
Decision code: APPR
Date received: 2022-03-07
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for Merlin Patient Care System (PCS) 3650 Model 3330 v25.8.1 software and Merlin 2 PCS Model MER3400 vl.8.1 software to improve the accuracy of the remaining battery longevity estimate by the programmer.