PMA P140033S100

Device: Tendril™ MRI Pacing Leads / Assurity MRI, Endurity MRI, Zenex MRI, Zenus MRI Pacemakers
Applicant: ABBOTT MEDICAL
PMA number: P140033
Supplement: S100
Product code: LWP
Decision date: 2025-11-20
Classification: Cardiovascular
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: approval for model line extensions for the Zenex™ MRI & Zenus™ MRI families of pacemakers and updated labeling for cardiac leads and additional pacemaker models

Current openFDA PMA Record#

Device: Tendril™ MRI Pacing Leads / Assurity MRI, Endurity MRI, Zenex MRI, Zenus MRI Pacemakers
Applicant: ABBOTT MEDICAL
PMA number: P140033
Supplement: S100
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2025-11-20
Decision code: APPR
Date received: 2025-09-10
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for model line extensions for the Zenex™ MRI & Zenus™ MRI families of pacemakers and updated labeling for cardiac leads and additional pacemaker models