PMA P880086S333

Device: Assurity, Assurity+, Endurity, Accent family of Pacemakers
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S333
Product code: DXY
Decision date: 2025-04-01
Classification: Cardiovascular
Generic name: implantable pacemaker Pulse-generator
Approval order statement: approval for the Merlin 2 Patient Care System (PCS) Programmer MER3700 with software Model MER3400 v1.9.1 and Merlin Live Connect Software, Model MLC1000.

Current openFDA PMA Record#

Device: Assurity, Assurity+, Endurity, Accent family of Pacemakers
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S333
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 2025-04-01
Decision code: APPR
Date received: 2023-12-29
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for the Merlin 2 Patient Care System (PCS) Programmer MER3700 with software Model MER3400 v1.9.1 and Merlin Live Connect Software, Model MLC1000.