PMA P030036

Device: MEDTRONIC SELECTSECURE LEAD MODEL 3830
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P030036
Supplement: S141
Product code: NVN
Decision date: 2026-10-16
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement: modify the manufacturing method for the inner assembly stringing process

Current openFDA PMA Record#

Device: MEDTRONIC SELECTSECURE LEAD MODEL 3830
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P030036
Supplement: S162
Product code: NVN
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date: 2026-10-16
Decision code: OK30
Date received: 2026-09-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: modify the manufacturing method for the inner assembly stringing process