PMA P030036S154

Device: MEDTRONIC SELECTSECURE LEAD MODEL 3830
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P030036
Supplement: S154
Product code: NVN
Decision date: 2025-10-09
Classification: Cardiovascular
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement: modifying the tooling used for the wire stripping and crimping processes and updated subassembly manufacturing parameter to support the updated tooling

Current openFDA PMA Record#

Device: MEDTRONIC SELECTSECURE LEAD MODEL 3830
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P030036
Supplement: S154
Product code: NVN
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date: 2025-10-09
Decision code: OK30
Date received: 2025-09-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: modifying the tooling used for the wire stripping and crimping processes and updated subassembly manufacturing parameter to support the updated tooling