PMA P030036S158

Device: SelectSecure Lead Model 3830
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P030036
Supplement: S158
Product code: NVN
Decision date: 2026-05-28
Classification: Cardiovascular
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement: approval for the addition of an alternate supplier of polyurethane resin for use in tissue-contacting components in the SelectSecure Model 3830 Lead family

Current openFDA PMA Record#

Device: SelectSecure Lead Model 3830
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P030036
Supplement: S158
Product code: NVN
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date: 2026-05-28
Decision code: APPR
Date received: 2026-02-27
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for the addition of an alternate supplier of polyurethane resin for use in tissue-contacting components in the SelectSecure Model 3830 Lead family