PMA P960013S131

Device: OptiSense™ Pacing Leads
Applicant: ABBOTT MEDICAL
PMA number: P960013
Supplement: S131
Product code: NVN
Decision date: 2025-11-20
Classification: Cardiovascular
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
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: OptiSense™ Pacing Leads
Applicant: ABBOTT MEDICAL
PMA number: P960013
Supplement: S131
Product code: NVN
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
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