PMA P970013S097

Device: Microny family of Pacemakers
Applicant: ABBOTT MEDICAL
PMA number: P970013
Supplement: S097
Product code: LWO
Decision date: 2025-06-17
Classification: Cardiovascular
Generic name: Pulse-generator, single chamber, sensor driven, implantable
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: Microny family of Pacemakers
Applicant: ABBOTT MEDICAL
PMA number: P970013
Supplement: S097
Product code: LWO
Generic name: Pulse-generator, single chamber, sensor driven, implantable
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.