PMA P830061S233

Device: CapSure Sense Lead 4574 CapSure Sense Lead 4073, 4074 Vitatron Crystalline Lead ICM09, ICM09B, ICM09JB Vitatron Excellen
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P830061
Supplement: S233
Product code: NVN
Decision date: 2026-02-10
Classification: Cardiovascular
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement: a new vapor degreasing solvent

Current openFDA PMA Record#

Device: CapSure Sense Lead 4574 CapSure Sense Lead 4073, 4074 Vitatron Crystalline Lead ICM09, ICM09B, ICM09JB Vitatron Excellen
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P830061
Supplement: S233
Product code: NVN
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date: 2026-02-10
Decision code: OK30
Date received: 2026-01-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a new vapor degreasing solvent