PMA P850089S173

Device: CapSure SP Novus Lead 5092 CapSure SP Z Lead 5033 Vitatron Impulse II Lead IHP09, IHP09B, IHP09JB
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P850089
Supplement: S173
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 SP Novus Lead 5092 CapSure SP Z Lead 5033 Vitatron Impulse II Lead IHP09, IHP09B, IHP09JB
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P850089
Supplement: S173
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