PMA P930039S275

Device: CapSureFix Novus Lead (5076); CapSureFix Novus Lead (4076); Vitatron Crystalline ActFix Lead (ICF09B); Vitatron Crystall
Applicant: Medtronic, Inc.
PMA number: P930039
Supplement: S275
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: CapSureFix Novus Lead (5076); CapSureFix Novus Lead (4076); Vitatron Crystalline ActFix Lead (ICF09B); Vitatron Crystall
Applicant: Medtronic, Inc.
PMA number: P930039
Supplement: S275
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