PMA P880086S342

Device: Assurity, Assurity+, Endurity, Accent family of Pacemakers
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S342
Product code: DXY
Decision date: 2025-06-17
Classification: Cardiovascular
Generic name: implantable pacemaker Pulse-generator
Approval order statement: approval for the AVEIR AR 2 LSP203A Leadless Pacemaker (LP), including updates to LP design, labeling, and Merlin PCS Programmer Software 3330 v28.5.x.

Current openFDA PMA Record#

Device: Assurity, Assurity+, Endurity, Accent family of Pacemakers
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S342
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 2025-06-17
Decision code: APPR
Date received: 2025-03-19
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for the AVEIR AR 2 LSP203A Leadless Pacemaker (LP), including updates to LP design, labeling, and Merlin PCS Programmer Software 3330 v28.5.x.