PMA P150035S036

Device: AVEIR Leadless Pacemaker, ventricular (LSP112V, LSP202V); Aveir Delivery Catheter (LSCD111, LSCD201)
Applicant: ABBOTT MEDICAL
PMA number: P150035
Supplement: S036
Product code: PNJ
Decision date: 2026-04-03
Classification: Cardiovascular
Generic name: Leadless pacemaker
Approval order statement: approval for a labeling expansion to update the labeling for the Aveir VR Leadless Pacemaker to include delivery of the device through the internal jugular vein.

Current openFDA PMA Record#

Device: AVEIR Leadless Pacemaker, ventricular (LSP112V, LSP202V); Aveir Delivery Catheter (LSCD111, LSCD201)
Applicant: ABBOTT MEDICAL
PMA number: P150035
Supplement: S036
Product code: PNJ
Generic name: Leadless pacemaker
Decision date: 2026-04-03
Decision code: APPR
Date received: 2026-01-20
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for a labeling expansion to update the labeling for the Aveir VR Leadless Pacemaker to include delivery of the device through the internal jugular vein.